Diadexus, Inc. - FORM 10-Q

Diadexus, Inc. - FORM 10-Q - May 10, 2012

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EXCEL - IDEA: XBRL DOCUMENT - Diadexus, Inc.	Financial_Report.xls
EX-32.1 - CERTIFICATION OF CEO PURSUANT TO 18 U.S.C. SECTION 1350 - Diadexus, Inc.	d336809dex321.htm
EX-31.2 - CERTIFICATION OF CFO PURSUANT TO EXCHANGE ACT RULE 13A-14(A) - Diadexus, Inc.	d336809dex312.htm
EX-10.2 - REBATE ADDENDUM - Diadexus, Inc.	d336809dex102.htm
EX-10.1 - PURCHASE AGREEMENT - Diadexus, Inc.	d336809dex101.htm
EX-31.1 - CERTIFICATION OF CEO PURSUANT TO EXCHANGE ACT RULE 13A-14(A) - Diadexus, Inc.	d336809dex311.htm
EX-32.2 - CERTIFICATION OF CFO PURSUANT TO 18 U.S.C. SECTION 1350 - Diadexus, Inc.	d336809dex322.htm
EX-10.6 - AMENDED AND RESTATED EMPLOYMENT AGREEMENT - Diadexus, Inc.	d336809dex106.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

x	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period Ended March 31, 2012

¨	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission File Number 0-26483

diaDexus, Inc.

(Exact name of Registrant as Specified in its Charter)


Delaware		94-3236309
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)


349 Oyster Point Boulevard South San Francisco, California		94080
(Address of principal executive offices)		(Zip Code)

(650) 246-6400

(Registrant’s telephone number, including area code)

Indicate by check mark whether the issuer (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one)

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x

The number of shares outstanding of the registrant’s common stock, $0.01 par value per share, was 53,067,045 as of May 4, 2012.

Table of Contents


PART I – FINANCIAL INFORMATION

Item 1.	Financial Statements (Unaudited)
	Condensed Balance Sheets	3
	Condensed Statements of Comprehensive Loss	4
	Condensed Statements of Cash Flows	5
	Notes to Condensed Financial Statements	6

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	18

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	24

Item 4	Controls and Procedures	24

PART II – OTHER INFORMATION

Item 1.	Legal Proceedings	25
Item 1A.	Risk Factors	25
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	34
Item 3.	Defaults Upon Senior Securities	35
Item 4.	Mine Safety Disclosures	35
Item 5.	Other Information	35
Item 6.	Exhibits	36
Signatures		38

PART I – FINANCIAL INFORMATION

Item 1.

Financial Statements

DIADEXUS, INC.

CONDENSED BALANCE SHEETS

(in thousands, except share data)


	March 31, 2012			December 31, 2011
	(unaudited)			(Note 1)
Assets
Current assets:
Cash and cash equivalents	$	12,203		$	10,484
Short-term investment securities		3,716			6,492
Accounts receivable, net of allowance for doubtful accounts of $4 and rebate reserve of $0 at March 31, 2012 and $4 and $20, respectively, at December 31, 2011		2,341			2,408
Inventories		163			117
Restricted cash		400			400
Assets held for sale		304			304
Prepaid expenses and other current assets		799			975

Total current assets		19,926			21,180
Long-term investments		—			250
Restricted cash		1,400			1,400
Property and equipment, net		1,485			1,350
Other long-term assets		150			175

Total assets	$	22,961		$	24,355

Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,281		$	882
Notes payable, current portion		790			372
Deferred revenues, current portion		342			331
Unfavorable lease obligations		515			492
Accrued and other current liabilities		2,053			2,469

Total current liabilities		4,981			4,546
Non-current portion of notes payable		4,119			4,526
Non-current portion of deferred revenue		454			530
Non-current portion of deferred rent		290			266
Non-current portion of unfavorable lease obligation		2,921			3,063
Other long term liabilities		301			284

Total liabilities		13,066			13,215

Commitments and contingencies (Note 14)
Stockholders’ equity:
Preferred Stock, $0.01 par value, 19,979,500 shares authorized; none issued and outstanding		—			—
Common stock, $0.01 par value; 100,000,000 shares authorized; 53,067,045 shares issued and outstanding at March 31, 2012 and December 31, 2011		531			531
Additional paid-in capital		205,634			205,557
Accumulated other comprehensive loss		(1	)		(5	)
Accumulated deficit		(196,269	)		(194,943	)

Total stockholders’ equity		9,895			11,140

Total liabilities and stockholders’ equity	$	22,961		$	24,355

See accompanying notes to condensed financial statements.

DIADEXUS, INC.

CONDENSED STATEMENTS OF COMPREHENSIVE LOSS

(in thousands, except share data)


	Three Months Ended March 31,
	2012			2011
	(unaudited)
Revenues:
License revenue	$	76		$	76
Royalty revenue		1,037			1,005
Product sales		3,830			2,240

Total revenues		4,943			3,321

Operating costs and expenses:
Product costs	$	1,719		$	1,132
Sales and marketing		1,182			1,107
Research and development		1,292			1,492
General and administrative		1,976			2,114

Total operating costs and expenses		6,169			5,845

Loss from operations		(1,226	)		(2,524	)
Interest income, interest expense and other income (expense), net:
Interest income		7			17
Interest expense		(101	)		—
Other income (expense), net		(3	)		—

Loss before income tax		(1,323	)		(2,507	)
Income tax provision		(3	)		(3	)

Net loss	$	(1,326	)	$	(2,510	)

Basic and diluted net loss per share:	$	(0.02	)	$	(0.05	)

Weighted average shares used in computing basic and diluted net loss per share		53,067,045			53,067,057

Other comprehensive income (loss), net of tax:
Net unrealized gain (loss) on available-for-sale securities		(1	)		(1	)

Comprehensive loss	$	(1,327	)	$	(2,511	)

See accompanying notes to condensed financial statements.

DIADEXUS, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(in thousands)


	Three Months Ended March 31,
	2012			2011
	(unaudited)
Operating activities:
Net loss	$	(1,326	)	$	(2,510	)
Adjustments to reconcile net loss to net cash used in operating activities:
Loss on disposal of property and equipment		2			—
Depreciation and amortization		124			130
Stock-based compensation		77			94
Amortization on investments		13			61
Provision for rebate reserve (reversal)		(20	)		13
Noncash other interest expense		7			6
Noncash interest associated with notes payable		34			—
Unfavorable lease		(119	)		(88	)
Changes in operating assets and liabilities
Accounts receivable		87			345
Accounts receivable from related party		—			175
Inventory		(46	)		(65	)
Prepaid expenses, other current assets and other long-term assets		188			(46	)
Accounts payable		403			75
Accrued liabilities and other long term liabilities		(216	)		(16	)
Deferred rent		24			21
Deferred revenue		(65	)		(50	)

Net cash used in operating activities		(833	)		(1,855	)

Investing activities:
Purchases of property and equipment		(465	)		(5	)
Maturities of available-for-sale investments		3,515			2,500
Purchases of available-for-sale investments		(498	)		(16,972	)

Net cash provided by (used in) investing activities		2,552			(14,477	)

Net increase (decrease) in cash and cash equivalents		1,719			(16,332	)
Cash and cash equivalents, beginning of period		10,484			20,394

Cash and cash equivalents, end of period	$	12,203		$	4,062

Supplemental disclosure:
Cash paid for interest	$	66		$	—
Acquisition of property and equipment in accounts payable	$	(4	)	$	—
Acquisition of property and equipment in accrued liabilities	$	(200	)	$	—

See accompanying notes to condensed financial statements.

diaDexus, Inc.

Notes to Condensed Financial Statements

1. Business Overview

diaDexus, Inc., a Delaware corporation (the “Company”), is a life sciences company focused on the development and commercialization of proprietary cardiovascular diagnostic products addressing unmet needs in cardiovascular disease. The Company is the successor to a company initially formed as a joint venture between SmithKlineBeecham Corporation (now GlaxoSmithKline LLC (“GlaxoSmithKline”)) and Incyte Pharmaceuticals, Inc. Upon formation, SmithKlineBeecham Corporation granted the Company an exclusive license to certain diagnostic intellectual property, including Lp-PLA₂, an inflammatory marker of cardiovascular risk.

The Company’s products, PLAC^® Tests, provide new information, over and above traditional risk factors, to help identify individuals at increased risk of suffering a heart attack or stroke. Some of these events may be reduced with earlier detection and more aggressive risk-reducing strategies, including treatment to lower LDL-cholesterol goals with statins. The Company has commercialized two PLAC Tests. One test measures the mass of circulating Lp-PLA₂ in the blood, the PLAC Test ELISA Kit. The PLAC Test ELISA Kit is the only blood test cleared by the U.S. Food and Drug Administration (“the FDA”) to aid in assessing risk for both coronary heart disease and ischemic stroke associated with atherosclerosis. The second test, the PLAC Test for Lp-PLA₂ Activity, is an enzyme assay for the quantitative determination of Lp-PLA₂ activity levels in human plasma and serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluation and patient risk assessment as an indicator of atherosclerotic cardiovascular disease. The Company is currently commercializing the PLAC Test ELISA Kit in the United States and Europe and the PLAC Test for Lp-PLA₂ Activity in Europe.

In June 2011, the Company submitted a premarket notification to the FDA seeking clearance under Section 510(k) of the Federal Food, Drug and Cosmetic Act (“FDCA”) to market its PLAC Test for Lp-PLA₂ Activity. The PLAC Test for Lp-PLA₂ Activity is capable of running on automated, high throughput clinical chemistry analyzers unlike the PLAC Test ELISA Kit. Future commercialization of an assay capable of running on automated, high throughput clinical chemistry analyzers may be important for the expansion of the PLAC Test market and revenue growth. In October 2011, the Company elected to withdraw this application following discussions with the FDA. The Company plans to develop a new submission. The Company is in the process of identifying completed clinical trials acceptable to the FDA from which blood samples of patient cohorts may be obtained and then tested to demonstrate the effectiveness of the new automated PLAC Test for Lp-PLA₂ Activity.

The Company has incurred substantial losses since inception and expects to continue to incur substantial net losses for at least the next few years. To date, the Company has funded its operations primarily through private placements of preferred stock and debt financing, as well as through revenue generated from the sale of products.

In September 2011, the Company entered into a loan and security agreement with a bank (see Note 9). This loan contains various covenants. If the Company breaches any of these covenants or is unable to make a required payment of principal or interest, or experiences a material adverse change to its business, it could result in a default under the loan. Additionally, the Company is required to achieve revenues equal to at least 80% of monthly projections approved by its Board of Directors and provided to the bank, and failure to do so could result in a default under the loan. Upon the occurrence of an event of default under the loan, the bank could elect to declare all amounts outstanding to be immediately due and payable. If the Company is unable to repay those amounts, the bank could proceed against the collateral granted to them to secure such indebtedness. The Company has pledged substantially all of its assets, other than its intellectual property, as collateral under the loan. The Company’s future liquidity requirements may increase beyond currently expected levels if it fails to maintain compliance with its covenants. In order to meet the future liquidity needs, the Company may become reliant on additional equity and/or debt financing. Additional funding may not be available when needed or on terms acceptable to the Company. Any additional equity financing may be dilutive to stockholders, and debt financing, if available, may involve restrictive covenants. The Company cannot assure you that it will be able to raise any such additional funding.

PLAC Test ELISA Kit

The Company introduced its initial PLAC Test ELISA Kit product in 2004. The PLAC Test ELISA Kit uses microplate technologies to measure levels of Lp-PLA₂. The infrastructure for performing microplate tests typically exists only at large and midsize clinical reference laboratories and large hospitals, which must be certified by the US Department of Health and Human Services (“DHHS”) for high-complexity diagnostics under the Clinical Laboratory Improvement Amendments (“CLIA”). Smaller hospitals and clinics can order the PLAC Test ELISA Kit for their patients from those institutions that are able to perform microplate tests and offer the PLAC Test ELISA Kit. Patients can have their blood drawn at a local laboratory and shipped to the more advanced institutions for analysis. The PLAC Test ELISA Kit is the only product the Company markets in both the United States and Europe.

diaDexus, Inc.

Notes to Condensed Financial Statements—continued

PLAC Test for Lp-PLA₂ Activity

The Company introduced the PLAC Test for Lp-PLA₂ Activity in Europe in March 2012. This PLAC Test for Lp-PLA₂ Activity is an enzyme assay for the quantitative determination of Lp-PLA₂ activity levels in human serum or plasma. The PLAC Test for Lp-PLA₂ Activity allows for the measurement of Lp-PLA₂ using automated clinical chemistry analyzer technology. This clinical chemistry technology is more prevalent than the microplate technology used for the PLAC Test ELISA Kit and is less difficult to operate, such that a broader array of institutions can conduct the test. This group includes clinical laboratories and hospitals of all sizes and physician operated laboratories (“POLs”). In addition, the sample handling requirements are much less stringent for the PLAC Test for Lp-PLA₂ Activity compared to the other PLAC Tests, allowing greater ease of use for those facilities processing specimens. The PLAC Test for Lp-PLA₂ Activity is currently available in Europe for use in conjunction with clinical evaluation and patient risk assessment as an indicator of atherosclerotic cardiovascular disease. The Company affixed the CE marking for this intended use by self certification in January 2012. The PLAC Test for Lp-PLA₂ Activity is available on a commercial basis only in Europe. The Company plans to pursue 510(k) clearance for this test from the FDA and eventually commercialize this assay format in the United States if the Company obtains FDA clearance.

All references in these notes to condensed financial statements to the “Company,” “we,” “us” and “our” refer to diaDexus, Inc. (f/k/a VaxGen, Inc.), a Delaware corporation, unless the context requires otherwise.

Basis of Presentation

The accompanying unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. In the opinion of management, the accompanying unaudited condensed financial statements have been prepared on a consistent basis with December 31, 2011 audited financial statements and includes all adjustments, consisting of normal recurring adjustments, which are necessary to fairly state the Company’s financial position as of March 31, 2012 and results of operations and cash flows for the three months ended March 31, 2012.

2. Summary of Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the Company’s annual report on Form 10-K for the year ended December 31, 2011, filed with the SEC on March 15, 2012, and have not changed as of March 31, 2012.

Recent Accounting Pronouncements

In December 2011, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2011-11, “Disclosure about Offsetting Assets and Liabilities.” ASU 2011-11 will require the Company to disclose information about offsetting and related arrangements to enable users of its financial statements to understand the effect of those arrangements on its financial positions. The new guidance is effective for annual reporting periods beginning on or after January 1, 2013, and interim periods within those annual periods. The disclosures are to be applied retroactively for all comparatives periods presented. The Company does not expect that this guidance will have an impact on its financial position, results of operations or cash flows as it is disclosure-only in nature.

In May 2011, the FASB amended its guidance to converge fair value measurement and disclosure guidance about fair value measurement under U.S. GAAP with International Financial Reporting Standards (“IFRS”). IFRS is a comprehensive series of accounting standards published by the International Accounting Standard Board. The amendment changes the wording used to describe many of the requirements in the U.S. GAAP for measuring fair value and for disclosing information about fair value measurements. For many of the requirements, the FASB does not intend for the amendment to result in a change in the application of the requirements in the current authoritative guidance. The amendment became effective prospectively for the Company’s interim period ended March 31, 2012. The Company adopted this guidance and the adoption did not have a material impact on the Company’s financial positions, results of operations or cash flows.

In June 2011, the FASB issued a new standard on the presentation of comprehensive income. The new standard eliminated the alternative to report other comprehensive income and its components in the statement of changes in equity. Under the new standard, companies can elect to present items of net income and other comprehensive income in one continuous statement or in two separate, but consecutive statements. We adapted the provisions of this guidance during the first quarter 2012.

3. Cash, Cash Equivalents and Investments

As part of its cash management program, the Company maintains a portfolio of marketable investment securities. The securities are investment grade and generally mature within one year and may include tax exempt securities and certificates of deposit. The fair value of substantially all securities is determined by quoted market prices. The Company maintains its cash in bank accounts, which at times may exceed federally insured limits. The Company has not experienced any losses on such accounts. The Company considers all highly liquid investments purchased with an original maturity of three months or less at the time of purchase to be cash equivalents.

diaDexus, Inc.

Notes to Condensed Financial Statements—continued

The following is a summary of cash, cash equivalents, and available-for-sale securities at March 31, 2012 and December 31, 2011 (in thousands):


	March 31, 2012
	Cost Basis		Unrealized Gains		Unrealized Losses			Estimated Fair Value
Cash and cash equivalents:
Cash	$	5,397	$	—	$	—		$	5,397
Money market funds		6,806		—		—			6,806

Total cash and cash equivalents	$	12,203	$	—	$	—		$	12,203

Available-for-sale marketable securities:
Commercial paper		999		—		—			999
Corporate notes		1,720		—		(1	)		1,719
Certificates of deposit		498		—		—			498
US government agency obligations		500		—		—			500

Total available-for-sale marketable securities	$	3,717	$	—	$	(1	)	$	3,716


	December 31, 2011
	Cost Basis		Unrealized Gains		Unrealized Losses			Estimated Fair Value
Cash and cash equivalents:
Cash	$	3,243	$	—	$	—		$	3,243
Money market funds		7,241		—		—			7,241

Total cash and cash equivalents	$	10,484	$	—	$	—		$	10,484

Available-for-sale marketable securities:
Commercial paper		3,147		—		(1	)		3,146
Corporate notes		2,850		—		(4	)		2,846
US government agency obligations		750		—		—			750

Total available-for-sale marketable securities	$	6,747	$	—	$	(5	)	$	6,742

Fair Value Measurements

In accordance with ASC 820, the Company discloses and recognizes the fair value of its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The guidance establishes three levels of the fair value hierarchy as follows:

Level 1: Observable inputs, such as quoted prices in active markets for identical assets or liabilities;

Level 2: Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities;

Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

diaDexus, Inc.

Notes to Condensed Financial Statements—continued

The following table represents the Company’s fair value hierarchy for its financial assets (cash equivalents and investments) measured at fair value on a recurring basis as of March 31, 2012 and December 31, 2011 (in thousands):


			Fair Value Measurements
	Balance at March 31, 2012		Quoted Prices In Active Markets for Identical Assets Level 1		Significant other Observable Inputs Level 2		Significant Unobservable Inputs Level 3
Assets:
Cash	$	5,397	$	5,397	$	—	$	—
Money market funds		6,806		6,806		—		—
Commercial paper		999		—		999		—
Corporate notes		1,719		—		1,719		—
Certificates of deposit		498		—		498		—
US government agency obligations		500		—		500		—
Restricted cash		1,800		—		1,800		—

	$	17,719	$	12,203	$	5,516	$	—


			Fair Value Measurements
	Balance as of December 31, 2011		Quoted Prices In Active Markets for Identical Assets Level 1		Significant other Observable Inputs Level 2		Significant Unobservable Inputs Level 3
Assets:
Cash	$	3,243	$	3,243	$	—	$	—
Money market funds		7,241		7,241		—		—
Commercial paper		3,146		—		3,146		—
Corporate notes		2,846		—		2,846		—
US government agency obligations		750		—		750		—
Restricted cash		1,800		—		1,800		—

	$	19,026	$	10,484	$	8,542	$	—

The fair value of the notes payable is valued based on level 2 inputs and approximates its book value. The fair value of the notes payable is based on the present value of expected future cash flows and assumptions about current interest rates and the credit worthiness of the Company. As of March 31, 2012, the notes payable is carried at face value of $5.0 million less any unamortized debt discount.

The carrying value of other financial instruments, including cash, accounts receivable, accounts payable and other payables, approximates fair value due to their short maturities.

4. Inventory

Inventory consists of the following (in thousands):


	March 31, 2012		December 31, 2011
Finished goods	$	106	$	71
Raw materials		57		46

	$	163	$	117

diaDexus, Inc.

Notes to Condensed Financial Statements—continued

5. Assets Held For Sale

Prior to the period reflected in this report, the Company had committed to a plan to sell the equipment related to its manufacturing facility and had determined that these assets met the criteria for, and had been classified as, “held for sale” in accordance with ASC Topic 360. The market approach was used in determining the fair market value of these assets.

Total assets held for sale as of March 31, 2012 and December 31, 2011 is as follows (in thousands):


			Fair Value Measurements Using
Description	March 31, 2012		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Three Months Ended March 31, 2012 Total Gains (Losses)
Assets held for sale	$	304	$	—	$	—	$	304	$	—


			Fair Value Measurements Using
Description	December 31, 2011		Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)		Year Ended December 31, 2011 Total Gains (Losses)
Assets held for sale	$	304	$	—	$	—	$	304	$	—

The measurement of the assets held for sale fair value incorporated significant unobservable inputs as a result of a lack of any available observable market information to determine the fair value. The calculation of the fair value of assets held for sale used a market valuation technique that relied on Level 3 inputs, including quoted prices for similar assets. There was no impairment charge for the three months ended March 31, 2012. The Company is committed to selling these assets in 2012 and any resulting gain or loss will be included in the statement of comprehensive loss.

6. Property, Plant and Equipment

Property and equipment are recorded at cost. Expenditures for major additions and improvements are capitalized, and maintenance and repairs are charged to expense as incurred. When property and equipment are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the results of operations for the respective period. Depreciation is provided over the estimated useful lives of the related assets using the straight-line method for financial statement purposes. The Company uses other depreciation methods for tax purposes where appropriate. The estimated useful lives for significant property and equipment categories are as follows:


Office and Laboratory equipment		3 years
Computer equipment and software		3 years
Leasehold improvements		Term of lease agreement

The following is a summary of property and equipment at cost less accumulated depreciation as of March 31, 2012 and December 31, 2011 (in thousands):


	March 31, 2012			December 31, 2011
Laboratory equipment	$	3,067		$	5,202
Leasehold improvements		602			8,283
Computer and software		317			1,916
Furniture and fixtures		163			835

		4,149			16,236
Less: Accumulated depreciation and amortization		(2,664	)		(14,886	)

	$	1,485		$	1,350

diaDexus, Inc.

Notes to Condensed Financial Statements—continued

Depreciation and amortization expense was $0.1 million and $0.1 million for the three months ended March 31, 2012 and 2011, respectively.

7. Total Accrued and Other Current Liabilities

Total accrued and other current liabilities include the following as of March 31, 2012 and December 31, 2011 (in thousands):


	March 31, 2012		December 31, 2011
Accrued payroll and related expenses	$	1,057	$	1,351
Accrued royalty expense		229		207
Accrued legal and patent expense		179		35
Accrued sales tax		168		126
Accrued consulting expenses		88		69
Property and equipment		—		200
Accrued audit fees		—		120
Accrued collaborative research obligations		—		96
Other current liabilities		332		265

Total accrued and other current liabilities	$	2,053	$	2,469

8. Concentration of Credit Risk

Revenues from the following four distributors and large laboratory customers represented a significant portion of total revenue for the three months ended March 31, 2012 and 2011 and accounts receivable as of March 31, 2012 and December 31, 2011:


	Revenue						Accounts Receivable
	March 31, 2012			March 31, 2011			March 31, 2012			December 31, 2011
Customer A		47	%		—	%		24	%		44	%
Customer B		12	%		11	%		18	%		13	%
Customer C		6	%		—	%		5	%		—	%
Customer D		5	%		16	%		5	%		15	%

Total		70	%		27	%		52	%		72	%

9. Notes Payable

In September 2011, the Company entered into a loan and security agreement with a bank to borrow up to $5,000,000, the entire amount of which was borrowed at a rate of 5.25% per annum. The loan is payable in 36 monthly installments which begin in October 2012, with interest only payments being made from October 2011 to September 2012. The Company paid an initial fee of $25,000 for access to this loan and will be required to pay an additional fee of $100,000 following repayment of the loan. The Company may prepay all, but not less than all, of the loaned amount with 30 days advance notice to the bank. If the loan is prepaid prior to September 24, 2012, the Company will be obligated to pay an additional prepayment fee equal to 1% of the principal amount prepaid. In connection with the loan, the Company issued a warrant to the bank to purchase 480,769 shares of the Company’s common stock (Note 13).

The term loan is secured by a first priority security interest on all of the Company’s assets excluding the Company’s intellectual property (except for rights to payment related to the sale, licensing or disposition of such intellectual property rights) and property not assignable without consent by a third party or with respect to which granting a security interest is contrary to law. In addition, the Company has agreed not to sell, assign, transfer, pledge or otherwise encumber its intellectual property to another entity without the bank’s approval or consent, subject to certain exceptions.

diaDexus, Inc.

Notes to Condensed Financial Statements—continued

The loan and security agreement contains customary representations and warranties, covenants, events of defaults and termination provisions. The affirmative covenants include, among other things, that the Company timely file taxes, maintain good standing and government compliance, achieve at least 80% of specified monthly revenue projections calculated on a trailing three months basis, maintain primary depository and operating accounts with the bank, maintain liability and other insurance, and provide security interests to the bank in the collateral of any subsidiary formed or acquired by the Company in the future. The negative covenants provide, among other things, that without the prior consent of the bank, the Company may not dispose of certain assets, engage in certain business combinations or acquisitions, incur additional indebtedness or encumber any of the Company’s property (subject to certain exceptions), pay dividends on the Company’s capital stock or make prohibited investments. The loan and security agreement provides that an event of default will occur if, among other triggers, (1) the Company defaults in the payment of any amount payable under the agreement when due, (2) there occurs any circumstance or circumstances that could reasonably be expected to result in a material adverse effect on the Company’s business, operations or condition, or on the Company’s ability to perform its obligations under the agreement, (3) the Company becomes insolvent, (4) the Company undergoes a change in control or (5) the Company breaches any negative covenants or certain affirmative covenants in the agreement or, subject to a cure period, otherwise neglects to perform or observe any material item in the agreement. The repayment of the term loan may be accelerated, at the option of the bank, following the occurrence of an event of default, which would require the Company to pay to the bank an amount equal to the sum of: (i) all outstanding principal plus accrued interest, (ii) the final payment, plus (iii) an early payment fee equal to 1% of the principal amount then required to be paid if such repayment is required prior to September 24, 2012, plus (iv) all other sums, that shall have become due and payable but have not been paid, including interest at the default rate with respect to any past due amounts. As of March 31, 2012, the Company was in compliance with all the covenants.

Future minimum payments for the notes payable are as follows (in thousands):


2012 (remainder of year)	$	616
2013		1,870
2014		1,781
2015		1,378

Total minimum payments		5,645
Less: Amount representing interest		(645	)

Present value of minimum payments	$	5,000
Less: Unamortized debt discount		(91	)

Notes payable, net	$	4,909

Less: Notes payable, current portion		790

Non-current portion of notes payable		4,119

10. Common Stock

On July 15, 2011, the Company amended its certificate of incorporation to increase the number of authorized shares of its common stock, par value of $0.01 per share, to 100,000,000. The holders of common stock are entitled to receive dividends, as, when and if declared by the Company’s Board of Directors out of funds legally available for distribution, subject to the restriction on dividends contained in the Company’s loan agreement with a bank (Note 9).

11. Basic and Diluted Net Loss per Share

Basic net loss per common share is based on the weighted average number of common shares outstanding during the period. Diluted net loss per common share is based on the weighted average number of common shares and other dilutive securities outstanding during the period, provided that including these dilutive securities does not increase the net loss per share.

The effect of the options and warrants was anti-dilutive for the three months ended March 31, 2012 and 2011. The following table shows the total outstanding securities considered anti-dilutive and therefore, excluded from the computation of diluted net loss per share (in thousands):


	As of March 31,
	2012		2011
Options to purchase common stock		10,319		7,055
Warrants to purchase common stock		481		16

Total		10,800		7,071

diaDexus, Inc.

Notes to Condensed Financial Statements—continued

12. Stock Based Compensation

Stock Option Plans

1996 Stock Option Plan

The 1996 Stock Option Plan (the “Plan”) initially had 4,750,000 shares of common stock authorized for issuance and a provision that automatically increased this number by 3.5% of the issued and outstanding common stock on the last trading day of the December immediately preceding each fiscal year through January 2007. Options granted under the Plan may be designated as qualified or nonqualified at the discretion of the Compensation Committee of the Board of Directors. Generally, shares issuable upon exercise of options vest ratably over four years, beginning one year from the date of grant; however, options can vest upon grant. All options expire no later than 10 years from the date of grant. Qualified stock options are exercisable at not less than the fair market value of the stock at the date of grant, and nonqualified stock options are exercisable at prices determined at the discretion of the Board of Directors, but not less than 85% of the fair market value of the stock at the date of grant.

As of March 31, 2012, options for 6,398,904 shares were outstanding and 1,555,492 shares were available for grant under the Plan.

1998 Director Stock Option Plan

The 1998 Director Stock Option Plan (the “Director Plan”) for non-employee directors has 300,000 shares of common stock authorized for issuance. All grants under this plan were suspended in 2005. As of March 31, 2012, options for 170,000 shares were outstanding under the Director Plan.

Valuation Assumptions

The compensation expense related to stock options recognized was determined using the Black-Scholes option valuation model. Option valuation models require the input of subjective assumptions and these assumptions can vary over time. The weighted average assumptions used were as follows:


	Three Months Ended March 31,
	2012			2011
Dividend yield		0.0	%		0.0	%
Risk-free interest rate		0.49	%		1.56	%
Expected volatility		96.65	%		90.44	%
Forfeiture rate		13.24	%		11.57	%
Expected term (years)		4.12			4.27
Weighted-average grant date fair value	$	0.19		$	0.26

The expected stock price volatility assumption was determined by examining the historical volatilities for industry peers, as the Company did not have sufficient trading history for the Company’s common stock. The Company will continue to analyze the historical stock price volatility and expected term assumption as more historical data for the Company’s common stock becomes available. The risk-free interest rate assumption is based on the U.S. Treasury instruments whose term was consistent with the expected term of the Company’s stock options. The expected dividend assumption is based on the Company’s history and expectation of dividend payouts. Different estimates of volatility and expected term could materially change the value of an option and the resulting expense. The expected term of stock option represents the weighted-average period the stock options are expected to remain outstanding and is based on the options vesting terms, contractual terms and historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior.

diaDexus, Inc.

Notes to Condensed Financial Statements—continued

The following table summarizes stock compensation expense related to employee stock options and employee stock based compensation for the three months ended March 31, 2012 and 2011, which was incurred as follows: (in thousands)


	Three Months Ended March 31,
	2012		2011
Stock compensation expense:
Product costs	$	2	$	3
Research and development		17		22
Sales and marketing		13		13
General and administrative		45		56

Total stock compensation expense	$	77	$	94

Employee Stock-Based Compensation

The table below presents information related to stock option activity under the Plan, the Director Plan and certain option grants to employees and a director outside of the Plan, net of options previously exercised, as follows:


	Number of Options Outstanding			Weighted- Average Exercise Price		Weighted- Average Remaining Contractual Term (In years)		Aggregate Intrinsic Value
Outstanding at December 31, 2011		9,187,589		$	0.48
Options granted		1,141,000			0.28
Options exercised		—			—
Options cancelled/forfeited/expired		(9,685	)		0.26

Outstanding at March 31, 2012		10,318,904		$	0.46		6.85	$	174,239

Exercisable at March 31, 2012		4,607,080		$	0.69		4.30	$	72,809

Vested and expected to vest at March 31, 2012		9,291,721		$	0.48		6.59	$	156,061

The aggregate intrinsic value of stock options exercisable at March 31, 2012 was $73,000 and for in-the-money stock options outstanding was $174,000.

The following table summarizes information relating to stock options outstanding as of March 31, 2012:


	Options Outstanding						Options Exercisable
Range of Exercise Price	Number Outstanding		Weighted Average Remaining Contractual Life (In Years)		Weighted Average Exercise Price		Number Exercisable		Weighted Average Exercise Price
$0.14		114,000		9.71	$	0.14		—	$	—
$0.25		1,542,000		9.49		0.25		—		—
$0.26		5,600,973		4.92		0.26		3,640,452		0.26
$0.28		1,141,000		9.85		0.28		—		—
$0.29		1,255,931		9.36		0.29		545,066		0.29
$0.33 - $7.74		555,000		7.46		1.28		311,562		1.98
$8.74		20,000		1.65		8.74		20,000		8.74
$12.27		30,000		2.56		12.27		30,000		12.27
$14.30		20,000		0.85		14.30		20,000		14.30
$15.71		40,000		2.16		15.71		40,000		15.71

$0.14 - $15.71		10,318,904		6.85	$	0.46		4,607,080	$	0.69

The estimated fair value of grants of stock options to non-employees of the Company is charged to expense in the financial statements. These options generally vest monthly over one year.

Stock based compensation expense recognized during the three months ended March 31, 2012 and 2011 includes compensation expense for stock based awards granted to employees based on the grant date fair value estimated in accordance with the provisions of ASC 718. As of March 31, 2012, the total remaining unrecognized cost was approximately $0.9 million to be recognized over approximately three years.

diaDexus, Inc.

Notes to Condensed Financial Statements—continued

Shares Reserved for Future Issuance

The Company had reserved shares of common stock for future issuance at March 31, 2012 and 2011 as follows:


	As of March 31,
	2012		2011
Options to purchase common stock		10,318,904		7,055,244
Warrants to purchase common stock		480,769		16,000
Shares available for option grants		1,685,492		1,229,152

Total		12,485,165		8,300,396

In October 2004, the Company granted stock options for 30,000 shares outside the Company’s stock option plans to a new director with an exercise price of $12.27 per share. These options were granted with terms that are substantially in accordance with the Company’s standard stock option terms. As of March 31, 2012, none of these stock options have been exercised or repurchased.

In September 2011, the Company granted stock options for 1,530,000 shares outside the Company’s stock option plans to the Chief Executive Officer with an exercise price of $0.25 per share. These options were granted with terms that are substantially in accordance with the Company’s standard stock option terms. As of March 31, 2012, none of these stock options have been exercised or repurchased.

In October 2011, the Company granted stock options for 1,130,000 shares outside the Company’s stock option plans to the Chief Business Officer with an exercise price of $0.26 per share. These options were granted with terms that are substantially in accordance with the Company’s standard stock option terms. As of March 31, 2012, none of these stock options have been exercised or repurchased.

On February 1, 2012, the Company granted stock options for 1,060,000 shares outside of the Company’s stock option plans to the Chief Financial Officer with an exercise price of $0.28 per share. These options were granted with terms that are substantially in accordance with the Company’s standard stock option terms. As of March 31, 2012, none of these stock options have been exercised or repurchased.

13. Stock Warrants

The Company issues warrants to investors as part of its overall financing strategy. In connection with the loan and security agreement the Company entered into with a bank (Note 9) in September 2011, the Company issued a warrant to purchase 480,769 shares of the Company’s common stock, at an exercise price of $0.26 per share. The warrant expires in September 2018. The initial fair value of the warrant was calculated using the Black-Scholes option pricing model and the following assumptions: volatility of 88.03%, risk-free interest rate of 1.36%, exercise price of $0.26 and an expected life of 7 years. The fair value of the warrant was determined to be $94,000 and was recorded as equity in additional paid-in-capital and a discount to the carrying value of the loan. The discount is being amortized to interest expense using the effective interest rate method over the 48-month term of the loan. As of March 31, 2012, there were warrants outstanding to purchase 480,769 shares of the Company's common stock, with a weighted-average exercise price of $0.26 per share and an aggregate exercise price of $0.1 million.

The following table summarizes information about all warrants outstanding as of March 31, 2012:


	Warrants Outstanding						Warrants Exercisable
Exercise Price	Number Outstanding		Weighted Average Remaining Contractual Life (In Years)		Weighted Average Exercise Price		Number Exercisable		Weighted Average Exercise Price
$0.26		480,769		6.48	$	0.26		480,769	$	0.26

		480,769		6.48	$	0.26		480,769	$	0.26

diaDexus, Inc.

Notes to Condensed Financial Statements—continued

14. Leases, Commitments and Contingencies

The Company leases an office and laboratory facility (the “349 Facility”) under a long-term, non-cancelable operating lease agreement, which expires in December 2016. The Company also leased another office and laboratory facility (the “343 Facility”), and subleased a portion of that facility, until the Company’s underlying lease for that facility expired on January 1, 2012.

In 2010, the Company recorded a lease obligation associated with the 349 Facility, which contained a lease payment that exceeded current market rates. Accordingly, the Company recognized a $4.1 million unfavorable lease obligation, included in the accompanying balance sheet. The Company amortizes the unfavorable lease obligation using the effective interest rate method.

Rent expense for the Company’s facilities was $517,000 and $761,000 for the three months ended March 31, 2012 and 2011, respectively. The terms of the lease for the 349 Facility provides for rental payments on a graduated scale. The Company recognizes rent expense on a straight-line basis over the lease period. Deferred rent of $290,000 and $266,000 as of March 31, 2012 and December 31, 2011, respectively, is included in the accompanying balance sheet.

Rental income from the sublease of the 343 Facility for the three months ended March 31, 2012 and 2011 was $0 and $365,000, respectively. This has been included as a reduction to operating expenses for the three months ended March 31, 2011 in the statement of operations.

Future minimum lease payments under non-cancelable operating leases are as follows (in thousands):


	Operating Leases
2012 (remainder of year)	$	1,824
2013		2,505
2014		2,581
2015		2,658
2016		2,738

Total minimum lease payments	$	12,306

15. Income Taxes

Provision for Income Tax

The Company’s effective tax rate is 0% for income tax for the three months ended March 31, 2012 and the Company expects that its effective tax rate for the full year 2012 will be 0%. Based on the weight of available evidence, including cumulative losses since inception and expected future losses, the Company has determined that it is more likely than not that the deferred tax asset amount will not be realized and therefore a valuation allowance has been provided on net deferred tax assets.

Under the provisions of Section 382 and 383 of the Internal Revenue Code, a change of control, as defined, may impose an annual limitation on the amount of the Company’s net operating loss and tax credit carryforwards, and other tax attributes, that can be used to reduce future tax liabilities. As a result of a merger transaction involving the Company in 2010, certain of the Company’s tax attributes prior to the merger transaction are subject to an annual limitation of $240,000 for federal and state purposes

The Company files U.S. Federal and multiple state tax returns. The Company is currently not subject to any income tax examinations. Due to the Company’s losses, generally all years remain open.

Uncertain Tax Positions

Effective January 1, 2009, the Company adopted ASC 740-10, which requires that the Company recognize the financial statement effects of a tax position when it becomes more likely than not, based upon the technical merits, that the position will be sustained upon examination.

The gross amount of unrecognized tax benefits as of March 31, 2012 is $1.4 million, related to the reserve on R&D credits, none of which will affect the effective tax rate if recognized due to the valuation allowance. The Company does not expect any material changes in the next 12 months in unrecognized tax benefits.

The Company recognizes interest and/or penalties related to uncertain tax positions. To the extent accrued interest and penalties do not ultimately become payable, amounts accrued will be reduced and reflected in the period that such

diaDexus, Inc.

Notes to Condensed Financial Statements—continued

determination is made. The interest and penalties are recognized as other expense and not tax expense. As of March 31, 2012, there are zero accrued interest and penalties related to uncertain tax positions.

16. Subsequent Events

None

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

This discussion and analysis should be read in conjunction with our unaudited financial statements and related notes thereto appearing in Part I, Item 1 of this Quarterly Report on Form 10-Q and the risk factors described in Part II, Item 1A of this Quarterly Report.

This Quarterly Report includes “forward-looking statements” that are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Certain forward-looking statements can be identified by words such as “may,” “will,” “expects,” “plans,” “anticipates,” “intends,” “believes,” “could” or “would” or the negative thereof or other comparable terminology. All statements other than statements of historical fact are “forward-looking statements” for purposes of these provisions, including any statements of the plans and objectives of management, any statements regarding future operations, any statements regarding future economic conditions or performance and any statement of assumptions underlying any of the foregoing.

Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward–looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. We caution you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, the following:

•

our ability to submit a new 510(k) premarket notification for, and obtain FDA clearance of, our PLAC Test for Lp-PLA₂ Activity;

•

our ability to retain our CEO and other key employees, and to attract, retain and motivate other qualified personnel;

•

our ability to gain acceptance of our PLAC Test products in the marketplace, including our ability to demonstrate that treatment of individuals based on their Lp-PLA₂levels improves clinical outcomes in prospective clinical studies;

•

our business is characterized by a high degree of customer concentration and our largest customers may be able to exert downward pressure on our pricing;

•

our relationship with key customers, including GlaxoSmithKline, the licensor of Lp-PLA₂;

•

our reliance on a sole source third party manufacturer to manufacture our PLAC Test ELISA Kit;

•

third party payors’ acceptance of and reimbursement for the PLAC Tests;

•

our ability to develop and commercialize new products and services;

•

various risks associated with the international expansion of our business;

•

our ability to successfully launch and commercialize the PLAC Test for Lp-PLA₂ Activity in Europe, and our dependence on our distributors for foreign sales of the PLAC Test for Lp-PLA₂ Activity;

•

our ability to initiate and continue to manufacture the PLAC Test for Lp-PLA₂ Activity on our site in South San Francisco, California;

•

the effects of U.S. and foreign government regulation and our ability to comply with such regulations;

•

our significant corporate expenses, including real estate lease liabilities and expenses associated with being a public company;

•

our limited revenue and cash resources;

•

the adequacy of our intellectual property rights;

•

our ability to satisfy our obligations under our license agreements, to maintain our license rights under those license agreements and to enter into any necessary licenses on acceptable terms; and

•

the other risks described below in Part II, Item 1A (“Risk Factors”).

Any forward-looking statement included in this Quarterly Report speaks only as of the date hereof. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update any such forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Overview

We are a life sciences company focused on the development and commercialization of proprietary cardiovascular diagnostic products addressing unmet needs in cardiovascular disease. We are the successor to a company initially formed as a joint venture between SmithKlineBeecham Corporation (now GlaxoSmithKline LLC (“GlaxoSmithKline”)) and Incyte Pharmaceuticals, Inc. Upon formation, SmithKlineBeecham Corporation granted us an exclusive license to certain diagnostic intellectual property, including Lp-PLA₂, an inflammatory marker of cardiovascular risk.

Our products, PLAC^® Tests provide new information, over and above traditional risk factors, to help identify individuals at increased risk of suffering a heart attack or stroke. Some of these events may be reduced with earlier detection and more aggressive risk-reducing strategies, including treatment to lower LDL-cholesterol goals with statins. We have commercialized two PLAC Tests. One test measures the mass of circulating Lp-PLA₂ in the blood, the PLAC Test ELISA Kit. The PLAC Test ELISA Kit is the only blood test cleared by the FDA to aid in assessing risk for both coronary heart disease and ischemic stroke associated with atherosclerosis. The second test, the PLAC Test for Lp-PLA₂ Activity, is an enzyme assay for the quantitative determination of Lp-PLA₂ activity levels in human plasma and serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluation and patient risk assessment as an indicator of atherosclerotic cardiovascular disease. We are currently commercializing the PLAC Test ELISA Kit in the United States and Europe and the PLAC Test for Lp-PLA₂ Activity in Europe.

In June 2011, we submitted a premarket notification to the FDA seeking clearance under Section 510(k) of the FDCA to market our PLAC Test for Lp-PLA₂ Activity. The PLAC Test for Lp-PLA₂ Activity is capable of running on automated, high throughput clinical chemistry analyzers unlike the PLAC Test ELISA Kit. Future commercialization of an assay capable of running on automated, high throughput clinical chemistry analyzers may be important for the expansion of the PLAC Test market and revenue growth. In October 2011, we elected to withdraw this application following discussions with the FDA. We plan to develop a new submission. We are in the process of identifying completed clinical trials acceptable to the FDA from which blood samples of patient cohorts may be obtained and then tested to demonstrate the effectiveness of the new automated PLAC Test for Lp-PLA₂ Activity.

We have incurred substantial losses since inception, and expect to continue to incur substantial net losses for at least the next few years. To date, we have funded our operations primarily through private placements of preferred stock and debt financing, as well as through revenue generated from the sale of products.

We entered into a loan agreement with a bank in September 2011. The agreement contains certain financial and non-financial covenants. Our future liquidity requirements may increase beyond currently expected levels if we fail to maintain compliance with such covenants. In order to meet our future liquidity needs, we may become reliant on additional equity and/or debt financing. Additional funding may not be available when needed or on terms acceptable to us. Any additional equity financing may be dilutive to stockholders, and debt financing, if available, may involve restrictive covenants. We cannot assure you that we will be able to raise any such additional funding.

All references in this Quarterly Report on Form 10-Q to the “Company,” “we,” “us” and “our” refer to diaDexus, Inc. (f/k/a VaxGen, Inc.), a Delaware corporation, unless the context requires otherwise.

Critical Accounting Policies and Estimates

The accompanying discussion and analysis of our financial condition and results of operations is based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses, and related disclosures. On an ongoing basis, we evaluate these estimates. Estimates are based on historical experience, information received from third parties and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could therefore differ materially from those estimates under different assumptions or conditions.

Critical accounting estimates, as defined by the Securities and Exchange Commission (“SEC”), are those that are most important to the portrayal of our financial condition and results of operations and require our management’s most difficult and subjective judgments and estimates of matters that are inherently uncertain. The accounting policies and estimates that we consider to be critical, subjective, and requiring judgment in their application are summarized in “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2011 filed with SEC on March 15, 2012. There have been no significant changes to the accounting policies and estimates disclosed in our Form 10-K.

Results of Operations

For the Three Months Ended March 31, 2012 and 2011.

Revenues


	Three months ended March 31,				% Increase (Decrease)
	2012		2011		2011 to 2012
	(in thousands)
Revenues:
License revenue	$	76	$	76		—	%
Royalty revenue		1,037		1,005		3	%
Product sales		3,830		2,240		71	%

Total net revenues	$	4,943	$	3,321		49	%

Revenues by geography are based on the billing address of the customer. The following table sets forth revenues by geographic area (in thousands):


	Three months ended March 31,
	2012		2011
United States	$	4,884	$	3,283
Europe		27		36
Rest of the world		32		2

	$	4,943	$	3,321

Over 98% of our revenues were from the US geographic area for both the three months ended March 31, 2012 and 2011.

Revenues are generated from licensing fees, royalties earned, product sales, and contract arrangements. The accounting classification of revenue between royalties and product sales relates to the alternate sales channels used by the Company, and as such, we believe that operating performance is most effectively evaluated by examining total net revenues.

The increase in net revenues for the three months ended March 31, 2012 as compared to the three months ended March 31, 2011 reflects an increased volume demand for our PLAC Test ELISA Kit offset by a decline in average sales price for our product.

Our top four distributors and large laboratory customers accounted for 70% of our net revenues for the three months ended March 31, 2012, compared to 84% for the three months ended March 31, 2011. Because of this customer concentration and the timing of orders from these customers, our quarterly revenue may fluctuate materially. Our largest customers are able to exert greater influence over our product pricing, which has led to a decline in average sales price in recent quarters. Such downward pressure on our pricing has the potential to continue.

Product Costs


	Three Months Ended March 31,				% Increase (Decrease)
	2012		2011		2011 to 2012
	(in thousands)
Product costs	$	1,719	$	1,132		52	%

Product costs include our expenditures for cost of goods, manufacturing support, product supplies, quality control, personnel expenses and overhead allocations. The increase in product costs of $587,000 primarily reflects an increase in product-related materials and supplies costs of approximately $435,000 due to increased demand for our PLAC Tests, an increase in facilities related expense of $107,000 due to our relocation to a larger facility and an increase of $37,000 in equipment costs used to produce our PLAC Test ELISA Kit.

Sales and Marketing Expenses


	Three Months Ended March 31,				% Increase (Decrease)
	2012		2011		2011 to 2012
	(in thousands)
Sales and marketing	$	1,182	$	1,107		7	%

Sales and marketing expenses include our expenditures on customer support, medical and other consultant fees, marketing programs and materials, and personnel expenses. The increase in sales and marketing expenses of $75,000 primarily reflects higher personnel expenses of approximately $70,000 due to increased sales and marketing personnel, increase in travel expense of approximately $35,000 due to higher personnel and travels related to product launch in Europe, offset by a reduction in marketing program expenses of approximately $24,000.

We expect to identify and hire additional personnel to staff our sales and marketing department as we develop and commercialize new products to maintain and expand our position in the market for diagnostics in cardiovascular disease.

Research and Development Expenses


	Three Months Ended March 31,				% Increase (Decrease)
	2012		2011		2011 to 2012
	(in thousands)
Research and development	$	1,292	$	1,492		(13	)%

Research and development expenses include costs related to product development, regulatory support of our technology and other technical support costs, including salaries and consultant fees. The decrease in research and development expenses of $200,000 primarily reflects a reduction in personnel costs of approximately $156,000 due partly to departure of our former Chief Science Officer in October 2011, a reduction in expenses related to clinical studies of approximately $127,000, a reduction in lab and research costs of approximately $29,000 associated with product development during the three months ended March 31, 2012, offset by increase in facilities cost of approximately $115,000 due to our relocation to a larger facility.

General and Administrative Expenses


	Three Months Ended March 31,				% Increase (Decrease)
	2012		2011		2011 to 2012
	(in thousands)
General and administrative	$	1,976	$	2,114		(7	)%

General and administrative expenses include personnel costs for finance, administration, information systems and professional fees as well as facilities expenses. The decrease in general and administrative expenses of $138,000 primarily reflects reduction in facility costs, including a reduction of approximately $448,000 in facilities cost for the 343 Facility as compared to the three months ended March 31, 2011 due to the expiration of the associated facility lease in January 2012, a reduction in expenses due to higher allocation of facility cost to other functional areas of approximately $206,000, offset by loss of sublease income of approximately $365,000, an increase in legal and other professional service costs of approximately $81,000 and an increase in recruiting costs of approximately $75,000.

Interest Income, Interest Expense and Other Income (Expense), net


	Three Months Ended March 31,					% Increase (Decrease)
	2012			2011		2011 to 2012
	(in thousands)
Interest income, interest expense and other income (expense), net
Interest income	$	7		$	17		(59	)%
Interest expense		(101	)		—			*
Other income (expense), net		(3	)		—			*

Total net interest and other income (expense)	$	(97	)	$	17		(671	)%

*	Result not meaningful

Interest income is derived from cash balances and short term investments. Interest expense is based on outstanding debt obligations. The increase in net interest and other expense was primarily due to a debt facility we entered into in September 2011.

Income Taxes


	Three Months Ended March 31,						% Increase (Decrease)
	2012			2011			2011 to 2012
	(in thousands)
Income tax provision	$	(3	)	$	(3	)		—	%

We generated net loss for the three months ended March 31, 2012 and had no federal income tax provision. Our effective tax rate was 0% for income tax for the three months ended March 31, 2012 and we expect that our effective tax rate for the full year 2012 will be 0%. The $3,000 income tax provision represents minimum state taxes paid during 2012.

In addition, we have substantial net operating loss carry forwards available to offset future taxable income for federal and state income tax purposes. At March 31, 2012, we had unrecognized tax benefits totaling $1.4 million. Our ability to utilize our net operating losses may be limited due to changes in our ownership as defined by Section 382 of the Code.

Under the provisions of Sections 382 and 383 of the Internal Revenue Code, a change of control, as defined, may impose an annual limitation on the amount of the Company’s net operating loss and tax credit carryforwards, and other tax attributes that can be used to reduce future tax liabilities. As a result of a merger transaction involving us in 2010, certain of the Company’s tax attributes prior to the merger transaction are subject to an annual limitation of $240,000 for federal and state purposes.

Liquidity and Capital Resources

Since our inception, we have incurred losses, and we have relied primarily on private placements of preferred stock and debt financing, as well as on revenue generated from the sale of product, to fund our operations. As of March 31, 2012, we had an accumulated deficit of $196.3 million, working capital of $14.9 million and shareholders’ equity of $9.9 million. Based on our current operating plan, we believe that our existing cash, cash equivalents, and investment securities will be sufficient to cover our cash needs for operating activities and commitments for the next twelve months.

Cash, Cash Equivalents and Investments

As of March 31, 2012, we had cash, cash equivalents and short-term investments of $15.9 million, compared to $17.2 million at December 31, 2011. The decrease of $1.3 million primarily reflects cash used in operations of $0.8 million and purchases of property and equipment of $0.5 million.

Cash Flows from Operating Activities

Net cash used in operating activities was $0.8 million for the three months ended March 31, 2012, and was primarily related to net loss of $1.3 million, adjusted for non-cash items of $0.1 million in depreciation and amortization, and $0.4 million cash inflow related to changes in operating assets and liabilities.

Net cash used in operating activities was $1.9 million for the three months ended March 31, 2011, and was primarily related to net loss of $2.5 million, adjusted for non-cash items of $0.1 million of depreciation and amortization, $0.1 million in stock-based compensation and $0.4 million cash inflow related to changes in operating assets and liabilities.

Cash Flows from Investing Activities

Net cash provided by investing activities in the three months ended March 31, 2012 was $2.5 million, primarily due to investment maturities of $3.5 million. This was partially offset by $0.5 million in purchases of investments and $0.5 million in purchases of property and equipment.

Net cash used in investing activities in the three months ended March 31, 2011 was $14.5 million, primarily due to purchase of available-for-sale investments of $17.0 million partially offset by maturities of $2.5 million.

Other Information

Our future capital requirements will depend primarily upon our ability to maintain and grow our current product revenues, to develop and commercialize new products, to manage our obligations under real estate leases, to realize the sale of our assets held for sale, and to improve our reimbursement prospects from third-party payors, including:

•

Our ability to obtain regulatory approval for the PLAC Test for Lp-PLA₂ Activity in the United States;

•

The rate of product adoption by laboratories and doctors;

•

Our ability to expand commercialization of the PLAC Test for Lp-PLA₂ Activity in Europe; and

•

The third-party payor community’s acceptance of and reimbursement for the PLAC Tests.

We expect to require additional financing and will seek to raise funds through equity or debt offerings, bank facilities, or other sources of capital. Additional funding may not be available when needed or on terms acceptable to us. Any additional equity financing may be dilutive to stockholders, and debt financing, if available, may involve restrictive covenants. We cannot assure you that we will be able to raise any such additional funding.

In September 2011, we entered into a loan and security agreement with a bank (see Note 9 of the Notes to Condensed Financial Statements included in this Quarterly Report on Form 10-Q). This loan contains various covenants.

If we breach any of these covenants or are unable to make a required payment of principal or interest, or experience a material adverse change to our business, it could result in a default under the loan. Additionally, we are required to achieve revenues equal to at least 80% of monthly projections approved by our Board of Directors and provided to the bank, and failure to do so could result in a default under the loan. Upon the occurrence of an event of default under the loan, the bank could elect to declare all amounts outstanding to be immediately due and payable, which would increase our liquidity requirements beyond the currently expected levels. If we are unable to repay those amounts, the bank could proceed against the collateral granted to them to secure such indebtedness. We have pledged substantially all of our assets, other than our intellectual property, as collateral under the loan. We are in compliance with all the debt covenants as of March 31, 2012.

In order to meet future liquidity needs, we may become reliant on additional equity and/or debt financing.

Commitments and Contingencies

Our contractual obligations and future minimum lease payments that are non-cancelable at March 31, 2012 are disclosed in the following table (in thousands):


	Total		2012(1)		2013		2014		2015		2016
Debt obligations	$	5,645	$	616	$	1,870	$	1,781	$	1,378	$	—
Operating lease obligations		12,306		1,824		2,505		2,581		2,658		2,738

Total contractual commitments	$	17,951	$	2,440	$	4,375	$	4,362	$	4,036	$	2,738

(1)	Remainder of year.

Off-Balance Sheet Arrangements

As of March 31, 2012, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4)(ii) of SEC Regulation S-K.

Recent Accounting Pronouncements

In June 2011, the FASB issued a new standard on the presentation of comprehensive income. The new standard eliminated the alternative to report other comprehensive income and its components in the statement of changes in equity. Under the new standard, companies can elect to present items of net income and other comprehensive income in one continuous statement or in two separate, but consecutive statements. We adopted the provisions of this guidance during the first quarter 2012.

Item 3.

Quantitative and Qualitative Disclosure About Market Risk

In the normal course of business, our financial position is routinely subject to a variety of risks, including market risk associated with interest rate movement. We regularly assess these risks and have established policies and business practices intended to protect against these and other exposures. As a result, we do not anticipate material potential losses in these areas.

As of March 31, 2012, we had cash, cash equivalents and short-term investments of $15.9 million, consisting of cash, cash equivalents and highly liquid short-term investments and certificates of deposit. The values of our short-term investments will likely decline by an immaterial amount if market interest rates increase and, therefore, we believe our exposure to interest rate changes is immaterial. Declines of interest rates over time will however, reduce our interest income from short-term investments.

Item 4.

Controls and Procedures

Evaluation of Disclosure Controls and Procedures

We have performed an evaluation under the supervision and with the participation of our management, including our principal executive and financial officer, of the effectiveness of our disclosure controls and procedures, as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on that evaluation, our management, including our principal executive and financial officer, concluded that our disclosure controls and procedures were effective as of March 31, 2012 to provide reasonable assurance that information required to be disclosed by us in the reports filed or submitted by us under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to management, including our principal executive and financial officer, as appropriate to allow timely decisions regarding required disclosures.

Changes in Internal Controls

There were no changes in our internal control over financial reporting during the quarter ended March 31, 2012 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Inherent Limitations on Effectiveness of Controls

Internal control over financial reporting may not prevent or detect all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Projections of any evaluation of effectiveness of internal control to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Accordingly, our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met.

PART II — OTHER INFORMATION

Item 1.

Legal Proceedings

The Company is from time to time subject to various claims and legal actions during the ordinary course of business. The Company believes that there are currently no claims or legal actions that would reasonably be expected to have a material adverse effect on its results of operations or financial condition.

Item 1A.

Risk Factors

Investing in our common stock involves a very high degree of risk. You should carefully consider the risks described below and all of the other information in our filings under the Exchange Act before making any investment decisions regarding our common stock. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we do not know or that we currently deem immaterial may also negatively affect our business, financial condition, operating results, and prospects. In that case, the market price of our common stock could decline, and you could lose all or part of your investment.

Risks Relating to Our Business Operations

We have withdrawn our 510(k) premarket notification for FDA clearance of our PLAC Test for Lp-PLA₂ Activity, and we may be unable to submit a subsequent 510(k) premarket notification or to obtain clearance with respect to such application.

On June 17, 2011, we submitted a premarket notification to the FDA seeking clearance under Section 510(k) of the FDCA to market our PLAC Test for Lp-PLA₂ Activity. This new assay measures the activity levels of the Lp-PLA₂ enzyme in the blood, while the PLAC Test currently marketed in the United States utilizes an ELISA method that measures the concentration of the enzyme. The PLAC Test for Lp-PLA₂ Activity is capable of running on automated, high throughput clinical chemistry analyzers unlike the current PLAC Test ELISA Kit. Future commercialization of an assay capable of running on automated, high throughput clinical chemistry analyzers may be important for the expansion of the PLAC Tests market and revenue growth. On October 24, 2011, we elected to withdraw this application following discussions with the FDA. We plan to develop a new submission. We are in the process of identifying completed clinical trials acceptable to the FDA from which blood samples of patient cohorts may be obtained and then tested to demonstrate the effectiveness of the PLAC Test for Lp-PLA₂ Activity.

There can be no guarantee that we will identify appropriate clinical trials, or that serum samples can be obtained from such trials to support retesting of PLAC Test for Lp-PLA₂ Activity. We cannot assure you that the results of any such clinical trials will support the proposed clinical claims. There can be no guarantee that the FDA will clear the subsequent 510(k) submission on a timely basis, or at all. Failure to receive clearance for the PLAC Test for Lp-PLA₂ Activity on a timely basis (or at all) may result in a loss of potential customers and would have an adverse effect on our financial condition and our ability to maintain or expand our business.

Our future success depends on our ability to retain our Chief Executive Officer and other key employees and to attract, retain and motivate qualified personnel.

We depend on the efforts and abilities of our Chief Executive Officer, along with other senior management, our research and development staff and a number of other key management, sales, support, technical and administrative services personnel. Competition for experienced, high-quality personnel exists, and we cannot assure you that we can continue to recruit and retain such personnel. Our failure to hire, train and retain qualified personnel would impair our ability to develop new products and manage our business effectively.

We are an early stage company and have engaged in only limited sales and marketing activities for our first products, the PLAC Tests.

Our products may never gain significant acceptance in the marketplace and therefore never generate substantial revenue or profits for the Company. As is the case with all novel biomarkers, we must establish a market for our PLAC Tests and build that market through physician education and awareness programs. Publication in peer review journals of results from outcome studies using our products will be an important consideration in the adoption by physicians and in the coverage by insurers of our products. Our ability to commercialize successfully the PLAC Tests and other diagnostic products will depend on factors, including:

•

whether healthcare providers believe our PLAC Tests and any other diagnostic tests that we successfully develop provide sufficient incremental clinical utility;

•

whether we are able to demonstrate that treatment of individuals based on their Lp-PLA₂ levels improves clinical outcomes in prospective clinical studies; and

•

whether health insurers, government health programs and other third-party payors will cover and pay for our diagnostic tests and the amounts they will reimburse.

These factors may present obstacles to commercial acceptance of our products, and we may need to devote substantial time and money to surmount these obstacles, and the result might not be successful.

Our business is characterized by a high degree of customer concentration. Our four top customers accounted for 52% of our accounts receivable and 70% of our revenue as of and for the three months ended March 31, 2012, respectively. The loss of one or more of these customers or a decline in revenue from one or more of these customers could have a material adverse effect on our business, financial condition, and results of operations.

Sales to a limited number of large laboratory customers account for a significant portion of our revenue and accounts receivable. Our dependence on and the identity of our key customers may vary from period to period as a result of competition among our customers, developments related to our products, and changes in individual customers’ purchases of our products. The concentration of revenue from our top four customers was 70% and 84% for the three months ended March 31, 2012 and 2011, respectively. We may experience greater or lesser customer concentration in the future, depending on future commercial agreements and whether we are able to grow our revenue from the PLAC Test for Lp-PLA₂ Activity. However, it is likely that our revenue and profitability will continue to be dependent on a very limited number of large laboratory companies and distributors, and we may experience an even higher degree of customer concentration in the future. The loss of, material reduction in sales volume to, or significant adverse change in our relationship with any of our key customers could have a material adverse effect on our revenue in any given period and may result in significant annual and quarterly revenue variations. Moreover, our largest customers are able to exert greater influence over our product pricing, which has led to a decline in average sales price in recent quarters. Such downward pressure on our pricing has the potential to continue. In addition, we may be unable to collect related accounts receivables when due, which could have a material adverse effect on our business. The concentration of accounts receivable from our top four customers was 52% and 81% as of March 31, 2012 and 2011, respectively.

We rely on a sole source third party to manufacture our PLAC Test ELISA Kit. If this manufacturer is unable to supply our products in a timely manner, or at all, we may be unable to meet customer demand, which would have a material adverse effect on our business.

We currently depend on a sole source, third party manufacturer, BioCheck, Inc., to manufacture our PLAC Test ELISA Kit. We cannot assure you that this manufacturer will be able to provide the products in quantities that are sufficient to meet demand or at all, in a timely manner, which could result in decreased revenues and loss of market share. We also depend on other key vendors and suppliers of materials, some of which are sole source or for whom an alternative could be difficult to find. There may be delays in the manufacturing process over which we have no control, including shortages of raw materials, labor disputes, backlog and failure to meet FDA standards. We are aware that our sole source manufacturer relies on sole source suppliers with respect to materials used in our products. We rely on our third-party manufacturer to maintain their manufacturing facility in compliance with FDA and other federal, state and/or local regulations including health, safety and environmental standards. If they fail to maintain compliance with FDA or other critical regulations, they could be ordered to curtail operations, which would have a material adverse impact on our business. Increases in the prices we pay our manufacturer, or lapses in quality, such as failure to meet our specifications or the requirements of the Quality System Regulations, or QSR, and other regulatory requirements, could materially adversely affect our business. Any manufacturing defect or error discovered after our products have been produced and distributed could result in significant consequences, including costly recall procedures and damage to our reputation. Our ability to replace the existing manufacturer may be difficult, because the number of potential manufacturers is limited. If we do undertake to negotiate terms of supply with

another manufacturer or other manufacturers, our relationships with our existing manufacturer could be harmed. Any interruption in the supply of product, or the inability to obtain the product from alternate sources in a timely manner, could impair our ability to supply the PLAC Test ELISA Kit and to meet the demands of our customers, which would have a material adverse effect on our business.

We manufacture our PLAC Test for Lp-PLA₂ Activity on-site in South San Francisco, California. It is our first time manufacturing a product in house and we could experience process, quality control and shipping problems due to the early stage of manufacturing.

We have developed manufacturing of the PLAC Test for Lp-PLA₂ Activity in house. We are dependent on the expertise of the personnel that developed and manufacture the product. As with any new products, we could observe performance deviations that have not been apparent during development, including performance and stability of the PLAC Test for Lp-PLA₂ Activity. The discovery of such performance deviations or of any manufacturing problems may adversely affect our sales in Europe.

We rely on the commercial success of our PLAC Tests.

We are solely dependent on our product line of PLAC Tests. We expect that the PLAC Tests will account for a substantial portion of our revenue for the foreseeable future. We do not know if our PLAC Tests will be successful over the long-term and it is possible that the demand for the product may decline over time. Any decline in demand or failure of our PLAC Tests to penetrate current or new markets significantly could have a material adverse effect on our business, financial condition, and results of operations.

If third-party payors do not reimburse our customers for the use of our clinical diagnostic products or if they reduce reimbursement levels, our ability to sell our products will be harmed.

We sell our products primarily through distributors and to large laboratory customers, substantially all of which receive reimbursement for the health care services they provide to their patients from third-party payors, such as Medicare, Medicaid and other government programs, private insurance plans and managed care programs. Third-party payors are increasingly attempting to contain health care costs by limiting both coverage and the level of reimbursement for medical products and services. Increasingly, all payors are challenging the prices charged for diagnostic tests. Most of these third-party payors may deny coverage and reimbursement if they determine that a medical product was not medically necessary or not used in accordance with cost-effective treatment methods, as determined by the third-party payor, or was used for an unapproved indication.

In the United States, third-party payors generally require billing codes on claims for reimbursement that describe the services provided. For laboratory services, the American Medical Association (“AMA”) establishes most of the billing codes using a data code set called Current Procedural Terminology, or CPT, codes. Each third-party payor generally develops payment amounts and coverage policies for their beneficiaries or members that ties to the CPT code established for the laboratory test and, therefore, coverage and reimbursement may differ by payor even if the same billing code is reported for claims filing purposes. For laboratory tests without a specific billing code, payors often review claims on a claim-by-claim basis and there are increased uncertainties as to coverage and eligibility for reimbursement. Currently, the tests performed by our assays are described by existing CPT codes, but we cannot guarantee that the CPT codes will not be revised or new CPT codes will not be established for our future assays. If our customers are not reimbursed for our products, they may reduce or discontinue purchases of our products, which would cause our revenues to decline. Lower-than-expected, or decreases in, reimbursement amounts for tests performed using our products may decrease amounts physicians and other practitioners are able to charge patients, which in turn may adversely affect the willingness of physicians and other practitioners to purchase our products at prices we target, or at all. If we are unable to sell our products at target prices, our revenue and gross margins will suffer and our business could be materially harmed.

Our business, in particular the growth of our business, is dependent on our ability to successfully develop and commercialize novel diagnostic products and services based on biomarkers. If we fail to develop and commercialize diagnostic products, we may be unable to execute our business plan.

Our long-term ability to generate product-related revenue will depend in part on our ability to develop additional formats or versions of the PLAC Tests and other new diagnostic products. If internal efforts do not generate sufficient product candidates, we will need to identify third parties that wish to collaborate with us to develop new products and applications. Our ability to pursue successfully third-party relationships will depend in part on our ability to negotiate acceptable license and related agreements. Even if we are successful in establishing collaborative arrangements, they may never result in the successful development or commercialization of any product candidate or the generation of any sales or royalty revenues. In addition, rapid technological developments and innovations characterize the markets for our products and services. Our

success will depend in large part on our ability to correctly identify emerging trends, enhance capabilities, and develop and manufacture new products quickly, in a cost-effective manner, and at competitive prices. The development of new and enhanced products is a complex and costly process. We may need to make substantial capital expenditures and incur significant research and development costs to develop and introduce such new products and enhancements. Our choices for developing products may prove incorrect if customers do not adopt the products we develop or if the products ultimately prove to be medically or commercially unviable. The discovery of performance problems may adversely affect development schedules. If we fail to timely develop and introduce competitive new products or additional formats of our existing products, our business, may be materially adversely affected.

International expansion of our business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.

Our business strategy incorporates international expansion, including establishing and maintaining direct sales and physician outreach and education capabilities outside of the United States and expanding our relationship with distributors. Doing business internationally involves a number of risks, including:

•

multiple, conflicting and changing laws and regulations such as tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses;

•

failure by us or our distributors to obtain regulatory approvals for the use of our tests in various countries;

•

difficulties in staffing with managing foreign operations;

•

complexities associated with managing multiple payor reimbursement regimes or patient self-pay systems;

•

logistics and regulations associated with shipping, including infrastructure conditions and transportation delays;

•

limits in our ability to penetrate international markets if we are not able to process tests locally;

•

financial risks, such as longer payment cycles, difficulty collecting accounts receivable and exposure to foreign currency exchange rate fluctuations;

•

natural disasters, political and economic instability, including wars, terrorism, and political unrest, outbreak of disease, boycotts, curtailment of trade and other business restrictions; and

•

regulatory and compliance risks that relate to maintaining accurate information and control over sales and distributors’ activities that may fall within purview of the Foreign Corrupt Practice Act, its books and records provisions or its anti-bribery provisions.

Any of these factors could significantly harm our future international expansion and operations and, consequently, our revenues and results of operations.

Our dependence on distributors for foreign sales of our PLAC Test for Lp-PLA₂ Activity could limit or prevent us from selling our test in Europe and from realizing long-term international revenue growth.

As of March 31, 2012, we had exclusive distribution agreements for our products in 14 European countries, and we may enter into other similar arrangements in other countries in the future. We intend to grow our business internationally, and to do so we may need to attract additional distributors to expand the territories in which we sell our PLAC Test for Lp-PLA₂ Activity. Distributors may not commit the necessary resources to market and sell our PLAC Tests to the level of our expectations. If current or future distributors do not perform adequately, or we are unable to locate distributors in particular geographic areas, we may not realize long-term international revenue growth.

The requirements of being a public company have required and will continue to require significant resources, increase our costs and occupy our management, and we may be unable to comply with these requirements in a timely or cost-effective manner.

As a company with public reporting responsibilities, we have incurred and will continue to incur significant legal, accounting, and other expenses. Complying with rules, regulations and requirements applicable to public companies will require substantial effort. Among other things, we are required to:

•

prepare and file and distribute periodic and current reports under the Exchange Act for a larger operating business and comply with other Exchange Act requirements applicable to public companies;

•

formalize old and establish new internal policies, such as those relating to insider trading and disclosure controls and procedures;

•

involve and retain to a greater degree outside counsel and accountants in the above activities; and

•

establish and maintain an investor relations function, including the provision of certain information on our website.

Compliance with these rules and regulations will cause us to incur significant legal and financial compliance costs and will make some activities more time-consuming and costly than if we were a private company. The securities laws require, among other things, that we implement and maintain effective internal control for financial reporting and disclosure. In particular, we must perform system and process evaluation and testing of our internal control over financial reporting to allow management to report on the effectiveness of our internal control over financial reporting. Our testing may reveal deficiencies in our internal control over financial reporting that are deemed to be material weaknesses. We have incurred and expect to continue to incur significant expense and devote substantial management effort toward ensuring compliance with these requirements. Moreover, if we are not able to comply with these requirements in a timely manner, or if we identify deficiencies in our internal control over financial reporting that are deemed to be material weaknesses, the market price of our common stock could decline and we could be subject to sanctions or investigations by the SEC or other regulatory authorities, which would entail expenditure of additional financial and management resources.

Natural disasters, including earthquakes, may damage our facilities.

Our corporate and manufacturing facilities are located in California. Our facilities in California are in close proximity to known earthquake fault zones. As a result, our corporate, research and manufacturing facilities are susceptible to damage from earthquakes and other natural disasters, such as fires, floods and similar events. Although we maintain general business insurance against fires and some general business interruptions, there can be no assurance that the scope or amount of coverage will be adequate in any particular case. Insurance specifically for earthquake risks is not available on commercially reasonable terms.

Failure in our information technology and storage systems could significantly disrupt the operation of our business.

Our ability to execute our business plan depends, in part, on the continued and uninterrupted performance of our information technology systems, or IT systems. IT systems are vulnerable to damage from a variety of sources, including telecommunications or network failures, malicious human acts and natural disasters. Moreover, despite network security and back-up measures, some of our servers are potentially vulnerable to physical or electronic break-ins, computer viruses and similar disruptive problems. Despite the precautionary measures we have taken to prevent unanticipated problems that could affect our IT systems, sustained or repeated system failures that interrupt our ability to generate and maintain data could adversely affect our ability to operate our business.

Risks Relating to Government Regulations

We are subject to extensive regulation by the FDA and other regulatory agencies and failure to comply with such regulation could have a material adverse effect on our business, financial condition, and results of operations.

Our business and our medical device products, including our PLAC Tests, are subject to extensive regulation by the FDA and other federal, state, and foreign regulatory agencies. These laws and regulations govern many aspects of our products and operations, and the products and operations of our suppliers and distributors, including premarket clearance and approval, design, development and manufacturing, labeling, packaging, safety and adverse event reporting, recalls, storage, advertising, promotion, sales and record keeping. Failure to comply with these laws and regulations could result in, among other things, warning letters, civil or criminal penalties, injunctions, delays in clearance or approval of our products, withdrawal of cleared products, recalls, and other operating restrictions, all of which could cause us to incur significant expenses.

Before we can market or sell a new product or a significant modification to an existing product in the United States, we must obtain either clearance under Section 510(k) of the FDCA, or approval of a pre-market approval application, or PMA, from the FDA, unless an exemption applies. In the 510(k) clearance process, the applicant must demonstrate to the FDA’s satisfaction that a proposed device is “substantially equivalent” to a device legally on the market, known as a “predicate” device, with respect to intended use, technology and safety and effectiveness, in order to obtain clearance from the FDA to market the proposed device. Clinical data is sometimes required to support substantial equivalence. The PMA pathway requires an applicant to demonstrate the safety and effectiveness of the device based, in part, on extensive data, including, but not limited to, technical, preclinical, clinical trial, manufacturing, and labeling data. The FDA can delay, limit, or deny clearance or approval of a device for many reasons, including:

•

we may not be able to demonstrate to the FDA’s satisfaction that our products are substantially equivalent to lawful predicate device or safe and effective for their intended uses;

•

the data from our pre-clinical studies and clinical trials may be insufficient to support clearance or approval, where required;

•

the manufacturing process or facilities we use may not meet applicable requirements; and

•

changes in FDA clearance or approval policies or the adoption of new regulations may require additional data.

Further, any modification we make to a 510(k)-cleared device that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, design, or manufacture, would require us to seek a new 510(k) clearance or, possibly, approval of a PMA. The FDA requires every manufacturer to make this determination in the first instance, but the FDA may review any manufacturer’s decision. The FDA may not agree with our decisions regarding whether new clearances or approvals are necessary for changes to 510(k) cleared devices. If the FDA disagrees with our determination and requires us to submit new 510(k) notifications or PMAs for modifications to our previously cleared products for which we have concluded that new clearances or approvals are unnecessary, we may be required to cease marketing or to recall the modified product until we obtain clearance or approval, and we may be subject to significant regulatory fines or penalties.

Even when a product reaches the market, the subsequent discovery of previously unknown problems, such as material deficiencies or defects in design, labeling, or manufacture, or a potential unacceptable risk to health, with a product may result in restrictions on the product, including recall or withdrawal of the product from the market, and/or a requirement to submit a new 510(k) submission or PMA for the product in order to support continued marketing.

We and our suppliers are subject to inspections by the FDA and other regulatory agencies and deficiencies identified during these audits could have a material adverse effect on our results of operations.

Once regulatory clearance or approval has been granted, the product and its manufacturer are subject to continual review by the FDA and other regulatory authorities. For example, we are also subject to routine inspection by the FDA and certain state agencies for compliance with the QSR, which establishes the good manufacturing practices for medical devices, and Medical Device Reporting regulations, which require us to report to the FDA any incident in which one of our products may have caused or contributed to a death or serious injury or malfunctioned in a way that could cause death or serious injury. Although we believe that we have adequate processes in place to ensure compliance with these and other postmarket requirements, the FDA or other regulatory bodies could disagree and take enforcement action including issuing warning letters, untitled letters, fines, injunctions, consent decrees or civil penalties, or imposing operating restrictions or partial suspension or total shutdown of manufacturing, selling or exporting our products, among other sanctions, if it concludes that we are out of compliance with applicable regulations or if it concludes that our products pose an unacceptable risk to health or are otherwise deficient in design, labeling or manufacture. Further, the ability of our suppliers to supply critical components or materials and of our distributors to sell our products could be adversely affected if their operations are determined to be out of compliance. The FDA and other regulatory bodies could also require us to recall products if we fail to comply with applicable regulations. Such actions by the FDA and other regulatory bodies would adversely affect our revenues and results of operations.

We are and will be subject to new regulations which could have a material adverse effect on our results of operations.

Many national, regional, and local laws and regulations, including the recently-enacted healthcare reform legislation, have not been fully implemented by the regulatory authorities or adjudicated by the courts, and their provisions are open to a variety of interpretations. In the ordinary course of business, we must frequently make judgments with respect to compliance with applicable laws and regulations. If regulators subsequently disagree with the manner in which we have sought to comply with these regulations, we could be subjected to various sanctions, including substantial civil and criminal penalties, as well as product recall, seizure or injunction with respect to the sale of our products. Such sanctions could severely impair our reputation within the industry and any limitation on our ability to manufacture and market our products could have a material adverse effect on our business. In addition, in January 2011, the FDA announced twenty-five action items it intends to take in reforming the 510(k) premarket review program. The FDA issued its recommendations and proposed action items in response to concerns from both within and outside of the FDA about the 510(k) program. Although the FDA has not detailed the specific modifications or clarifications that the Agency intends to make to its guidance, policies, and regulations pertaining to the review and regulation of devices such as ours which seek and receive marketing clearance through the 510(k) process, the FDA’s announced action items signal that additional regulatory requirements are likely. For example, in July 2011, the FDA issued a draft guidance document intended to clarify when changes to a cleared 510(k) warrant submission of a new 510(k), which many observers believe will result in an increase in the number of 510(k)s submitted to the FDA. The FDA intends to issue a variety of additional draft guidance and regulations over the coming months and years which would, among other things, establish a Unique Device Identification System and clarify the FDA’s use and application of several key terms in the 510(k) review process. These reforms, when fully implemented, could impose additional regulatory requirements upon us which could delay our ability to obtain new clearances, increase the cost of compliance, or restrict our ability to maintain our current 510(k) clearances.

Healthcare reform and its restrictions on coverage and reimbursement may adversely affect our profitability.

Legislation both proposed and passed has had an impact on reimbursement levels for diagnostic services, including laboratory tests. For instance, in March 2010, U.S. President Obama signed the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “PPACA”), which makes a number of substantial changes in the way health care is financed by both governmental and private insurers. Among other things, the PPACA mandates a reduction in payments for clinical laboratory services paid under the Medicare Clinical Laboratory Fee Schedule of 1.75% for the years 2011 through 2015. A productivity adjustment also is made to the fee schedule payment amount. In addition, on February 22, 2012, the President signed the Middle Class Tax Relief and Job Creation Act of 2012, which, among other things, mandated an additional change in Medicare reimbursement for clinical laboratory services. This legislation requires a rebasing of the Medicare clinical laboratory fee schedule to effect a 2% reduction in payment rates otherwise determined for 2013, which in turn will serve as a base for 2014 and subsequent years. Further, with respect to the PPACA changes, the legislation establishes an Independent Payment Advisory Board (“IPAB”) to reduce the per capita rate of growth in Medicare spending. The IPAB has broad discretion to propose policies, which may have a negative impact on payment rates for services, including clinical laboratory services, beginning in 2016, and for hospital services beginning in 2020.

Although some of these provisions may negatively impact payment rates for clinical laboratory services, the PPACA also extends coverage to approximately 32 million previously uninsured people, which may result in an increase in the demand for our tests and services. A number of state governors have strenuously opposed the mandatory purchase of insurance, known as the individual mandate, and initiated lawsuits challenging the constitutionality of certain provisions of the PPACA. Many of these challenges are still pending final adjudication in several jurisdictions, including the United States Supreme Court. Congress has also proposed a number of legislative initiatives, including possible repeal of the PPACA. At this time, it remains unclear whether there will be any changes made to the PPACA, whether to certain provisions (including the IPAB) or its entirety.

In addition, other legislative changes have been proposed and adopted since the PPACA was enacted. Most recently, on August 2, 2011, the President signed into law the Budget Control Act of 2011, which, among other things, creates the Joint Select Committee on Deficit Reduction to recommend proposals in spending reductions to Congress. The Joint Select Committee did not achieve a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, starting in 2013. The full impact on our business of the PPACA and the new law is uncertain. Levels of reimbursement may decrease in the future, and future legislation, regulation or reimbursement policies of third-party payors may adversely affect the demand for and price levels of our products.

We are subject to healthcare laws, regulation and enforcement; our failure to comply with those laws could have a material adverse effect on our results of operations and financial conditions.

We are also subject to healthcare fraud and abuse regulation and enforcement by both the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include:

•

the federal Health Insurance Portability and Accountability Act of 1996 as amended by the Health Information Technology for Economic and Clinical Health Act, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information;

•

the federal healthcare programs’ Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;

•

federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent;

•

federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; and

•

state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers. If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, the curtailment or restructuring of our operations, the exclusion from participation in federal and state healthcare programs and imprisonment, any of which could adversely affect our ability to operate our business and our financial results.

Risks Relating to Liquidity

Our term loan contains restrictions that limit our flexibility in operating our business, and the lender may accelerate repayment of amounts outstanding under certain circumstances.

In September 2011, we entered into a loan and security agreement with a bank. This loan contains various covenants that limit our ability to engage in specified types of transactions. These covenants limit our ability to, among other things:

•

Sell, transfer, lease or dispose of our assets;

•

Create, incur or assume additional indebtedness;

•

Encumber or permit liens on certain of our assets;

•

Pay dividends on, repurchase or make distributions with respect to our common stock;

•

Make specified investments;

•

Consolidate, merge, sell or otherwise dispose of all or substantially all of our assets; and

•

Enter into certain transactions with our affiliates.

If we breach of any of these covenants, are unable to make a required payment of principal or interest, or experience a material adverse change to our business, it could result in a default under the loan. Additionally, we are required to achieve revenues equal to at least 80% of monthly projections approved by our Board of Directors and provided to the bank, and our failure to do so could result in a default under the loan. Upon the occurrence of an event of default under the loan, the bank could elect to declare all amounts outstanding to be immediately due and payable. If we were unable to repay those amounts, the bank could proceed against the collateral granted to them to secure such indebtedness. We have pledged substantially all of our assets, other than our intellectual property, as collateral under the loan.

We will need to raise additional capital to support our operations in the future.

We will require additional funds to commercialize our products and develop new products. Our ability to fund our net losses and to conduct the required development activities related to any new product candidates will be significantly limited if we are unable to obtain the necessary capital. We will seek to raise funds through equity or debt offerings, bank facilities, or other sources of capital. Additional funding may not be available when needed or on terms acceptable to us. Any additional equity financing may be dilutive to stockholders, and debt financing, if available, may involve restrictive covenants. We cannot assure you that we will be able to raise any such additional funding.

We are an early stage company with a history of losses, we expect to incur losses for at least the next few years, and we may never achieve profitability.

We have incurred substantial net losses since our inception. Our accumulated deficit was approximately $196.3 million at March 31, 2012. For the three months ended March 31, 2012 and 2011, we incurred a net loss of $1.3 million and $2.5 million, respectively. We expect to continue to incur substantial net losses for at least the next few years. If we are unable to execute our commercialization strategy to achieve profitability, or if the time required to achieve profitability is longer than we anticipate, we may not be able to continue our business.

We have liabilities for real estate leases in excess of what is necessary for our current business. We will incur these additional expenses until we are able to sublease a portion of our larger leased facility.

We have a significant real estate lease for a facility of approximately 65,000 square feet with current monthly minimum required expenses of approximately $220,000. The term of the lease continues until December 31, 2016. Until such time that we are able to sublease a portion of the facility, we will incur liabilities for real estate leases significantly in excess of what is necessary for our current business. We may never be able to sublease a portion of the facility.

Risks Relating to Intellectual Property

If the combination of patents, trade secrets, trademarks, and contractual provisions that we rely on to protect our intellectual property proves inadequate, our ability to successfully commercialize our products will be harmed and we may never be able to operate our business profitably.

Our success depends, in large part, on our ability to protect proprietary discoveries, technology, and diagnostic tests that we develop under the patent and other intellectual property laws of the United States and other countries, so that we can seek to prevent others from unlawfully using our inventions and proprietary information.

Additionally, we have filed or have license rights to a number of patent applications that are in an early stage of prosecution, and we cannot make any assurances that any of the pending patent applications will result in patents being issued. In addition, due to technological changes that may affect our proposed products or judicial interpretation of the scope of our patents, our proposed products might not, now or in the future, be adequately covered by our patents.

Moreover, the U.S. Leahy-Smith America Invents Act, enacted in September 2011, brings significant changes to the U.S. patent system, which include a change to a “first to file” system from a “first to invent” system and changes to the procedures for challenging issued patents and disputing patent applications during the examination process, among other things. The effects of these changes on our patent portfolio and business have yet to be determined, as the U.S. Patent and Trademark Office must still implement regulations relating to these changes and U.S. courts have yet to address the new provisions, but in any event, these changes could increase the costs and uncertainties surrounding the prosecution of our patent applications and the enforcement or defense of our patent rights.

Furthermore, there have been several cases involving patents claiming genetic materials and information, and diagnostic products and methods based on genetic materials and information, that are pending in U.S. courts or have been decided by the U.S. Supreme Court that may impact our business. On March 20, 2012, in Mayo Collaborative Services, DBA Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc., the U.S. Supreme Court issued an opinion holding that the processes claimed by Prometheus’ patent were not patent eligible because these processes—determining the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm—merely apply laws of nature and are not themselves patentable. Additionally, a suit brought by multiple plaintiffs, including the American Civil Liberties Union, or ACLU, against Myriad Genetics and the USPTO, could also impact biotechnology patents. The Federal Circuit issued a written decision on July 29, 2011 that reversed the U.S. District Court for the Southern District of New York's ruling that Myriad's composition claims to "isolated" DNA molecules cover unpatentable subject matter. However, the Federal Court affirmed the District Court's decision that Myriad's method claims directed to simply "comparing" or "analyzing" DNA sequences without a "transformation" step are not patentable. The U.S. Supreme Court granted certiorari in the Myriad case , vacated the Federal Circuit decision and remanded the case back the Federal Circuit for further consideration of patentability in light of the Supreme Court’s decision in Mayo v. Prometheus. It is unknown whether or how pending cases will be decided. It is also unknown what impact, if any, the Prometheus decision or decisions in such pending cases will have on gene patents or diagnostic method patents generally or our ability to obtain or enforce such patents in the future.

We license key intellectual property from GlaxoSmithKline and ICOS, and our contractual relationships have certain limitations.

We have an exclusive license from GlaxoSmithKline and a co-exclusive license from ICOS Corporation (“ICOS”) to practice and commercialize technology covered by several issued and pending United States patents and their foreign counterparts. The issued patents that relate to the Company’s current business have expiration dates ranging from 2013 to 2016.

Several of our collaboration agreements with GlaxoSmithKline and ICOS provide licenses to use intellectual property that is important to our business, and we may enter into additional agreements in the future with GlaxoSmithKline or with other third parties that change licenses of valuable technology. Current licenses impose, and future licenses may impose, various commercialization, milestone and other obligations on us, including the obligation to terminate our use of patented subject matter under certain circumstances. If a licensor becomes entitled to, and exercises, termination rights under a license, we could lose valuable rights and our ability to develop our current and future products. Our business may suffer if any current or future licenses terminate, if the licensors fail to abide by the terms of the license or fail to prevent infringement by third parties, if the licensed patents or other rights are found to be invalid or if we are unable to enter into necessary licenses on acceptable terms.

Any inability to protect our proprietary technologies and product candidates adequately could harm our competitive position.

We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that our proprietary technologies are covered by valid and enforceable patents or are effectively maintained as trade secrets. We plan to continue to apply for patents covering our technologies and products as we deem appropriate. We cannot make assurances that our pending patent applications will issue as patents and, if they do, whether the scope of such claims will be sufficiently broad to prevent third parties from utilizing our technologies, commercializing our discoveries or developing competing products. Any patents we currently hold, or obtain in the future, may not be sufficiently broad to prevent others from utilizing our technologies, commercializing our discoveries, or developing competing technologies and products. Furthermore, third parties may independently develop similar or alternative technologies or design around our patented technologies. Third parties may challenge or invalidate our patents, or our patents may fail to provide us with any competitive advantage.

We have rights to patents and patent applications owned by GlaxoSmithKline, Human Genome Sciences, Inc. (“Human Genome Sciences”) and ICOS that provide important protection on the composition of matter and utility of our products and product candidates. We do not, however, directly control the prosecution and maintenance of all of these patents. GlaxoSmithKline, Human Genome Sciences, and ICOS may not fulfill their obligations as licensors and may allow these patents to go abandoned or may not pursue meaningful claims for our products. Also, while the United States Patent and Trademark Office has issued diagnostic patents covering utility or methods, we do not know whether or how courts will enforce these patents. If a court finds these types of inventions to be unpatentable or interprets them narrowly, the benefits of our patent strategy may not materialize. If any or all of these events occur, they could diminish the value of our intellectual property.

Risks Relating to Our Stock

Our stock price is likely to be volatile.

Currently, our common stock is quoted on the OTC Bulletin Board. Stocks traded “over the counter” typically are subject to greater volatility than stocks traded on stock exchanges, such as the NASDAQ Stock Market, due to the fact that OTC trading volumes are generally significantly lower than those on stock exchanges. This lower volume may allow a relatively few number of stock trades to greatly affect the stock price, particularly where the trading price of the stock price is relatively low. The trading price of our common stock has been and is likely to continue to be extremely volatile. Some of the many factors that may cause the market price of our common stock to fluctuate include, in no particular order:

•

Actions taken by regulatory authorities with respect to our products;

•

The progress and results of our product development efforts;

•

The outcome of legal actions to which we may become a party;

•

Our ability to commercialize the products, if any, that we are able to develop;

•

Changes in our capital structure, such as future issuances of securities or the incurrence of additional debt; and

•

Restatements of our financial results and/or material weaknesses in our internal controls.

The stock markets and the markets for medical diagnostics and biotechnology stocks in particular, have experienced volatility that has often been unrelated to the operating performance of particular companies. These broad market fluctuations may adversely affect the trading price of our common stock. Investors may not be able to sell when they desire due to insufficient buyer demand and may realize less than, or lose all of, their investment.

We are not currently listed on a national exchange and there can be no assurance we will ever be listed.

As a result of our failure to make timely filings of financial statements, we were delisted from The NASDAQ Stock Market in 2004. Currently, our common stock is quoted on the OTC Bulletin Board under the symbol DDXS.OB. We have not yet applied for our common stock to be listed on a national exchange, and we do not currently meet all of the requirements for listing or relisting on the NASDAQ Stock Market. We do not know when, if ever, our common stock will be listed on a national stock exchange. In addition, we cannot be certain that The NASDAQ Stock Market will approve our stock for relisting or that any other exchange will approve our stock for listing. In order to be eligible for relisting or listing, we must meet the initial listing criteria for The NASDAQ Stock Market or another national exchange, including a minimum per share price.

Our charter documents and Delaware law may discourage an acquisition of the Company.

Provisions of our certificate of incorporation, bylaws, and Delaware law could make it more difficult for a third-party to acquire us, even if doing so would be beneficial to our stockholders. We may issue shares of preferred stock in the future without stockholder approval and upon such terms as our Board of Directors may determine. Our issuance of this preferred stock could have the effect of making it more difficult for a third-party to acquire, or of discouraging a third-party from acquiring, a majority of our outstanding stock. Our bylaws also provide that special stockholders meetings may be called only by our Board of Directors, Chairperson of the Board of Directors, or by our Chief Executive Officer or President, with the result that any third-party takeover not supported by the Board of Directors could be subject to significant delays and difficulties.

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds.

None

Item 3.

Defaults Upon Senior Securities.

None

Item 4.

Mine Safety Disclosures.

Not applicable

Item 5.

Other Information.

None

Item 6.

Exhibits


Exhibit No.		Description

3.1		Restated Certificate of Incorporation of the registrant (incorporated by reference to Exhibit 3.1 to the registrant’s Quarterly Report on Form 10-Q (file no. 0-26483) for the fiscal quarter ended September 30, 2010, filed on November 15, 2010)

3.2		Certificate of Change of Registered Agent and Registered Office (incorporated by reference to Exhibit 3.1 to the registrant’s Current Report on Form 8-K (file no. 0-26483), filed on January 25, 2011)

3.3		Amendment to Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the registrant’s Current Report on Form 8-K (file no. 0-26483), filed on July 18, 2011)

3.4		Amended and Restated Bylaws of the registrant (incorporated by reference to Exhibit 3.2 to the registrant’s Current Report on Form 8-K (file no. 0-26483), filed on November 5, 2010)

10.1*		Purchase Agreement, effective as of January 1, 2012, by and between diaDexus, Inc. and Health Diagnostics Laboratory

10.2*		Rebate Addendum, effective as of March 1, 2012, by and between diaDexus, Inc. and Health Diagnostics Laboratory

10.3		Offer Letter, dated January 8, 2012, by and between diaDexus, Inc. and Jean-Frédéric Viret (incorporated by reference to Exhibit 10.61 to the registrant’s Annual Report on Form 10-K (file no. 0-26483), for the fiscal year ended December 31, 2011, filed on March 15, 2012)

10.4		Stock Option Agreement, dated February 1, 2012, by and between diaDexus, Inc. and Jean-Frédéric Viret (incorporated by reference to Exhibit 10.62 to the registrant’s Annual Report on Form 10-K (file no. 0-26483), for the fiscal year ended December 31, 2011, filed on March 15, 2012)

10.5		Change in Control and Severance Agreement, dated February 2, 2012, by and between diaDexus, Inc. and Jean-Frédéric Viret (incorporated by reference to Exhibit 10.63 to the registrant’s Annual Report on Form 10-K (file no. 0-26483), for the fiscal year ended December 31, 2011, filed on March 15, 2012)

10.6		Amended and Restated Employment Agreement, effective as of March 1, 2012, by and between diaDexus, Inc. and Emilia Zychlinsky Bulaevsky

31.1		Certification of Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a)

31.2		Certification of Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a)

32.1		Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

32.2		Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

101.INS**		XBRL Instance Document



101.SCH**		XBRL Taxonomy Extension Schema Document

101.CAL**		XBRL Taxonomy Extension Calculation Linkbase Document

101.LAB**		XBRL Taxonomy Extension Label Linkbase Document

101.PRE**		XBRL Taxonomy Extension Presentation Linkbase Document

*	Certain portions have been omitted pursuant to a confidential treatment request. Omitted information has been filed separately with the SEC.

Pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, or Section 18 of the Securities Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

EXHIBIT INDEX


Exhibit No.		Description

3.1		Restated Certificate of Incorporation of the registrant (incorporated by reference to Exhibit 3.1 to the registrant’s Quarterly Report on Form 10-Q (file no. 0-26483) for the fiscal quarter ended September 30, 2010, filed on November 15, 2010)

3.2		Certificate of Change of Registered Agent and Registered Office (incorporated by reference to Exhibit 3.1 to the registrant’s Current Report on Form 8-K (file no. 0-26483), filed on January 25, 2011)

3.3		Amendment to Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the registrant’s Current Report on Form 8-K (file no. 0-26483), filed on July 18, 2011)

3.4		Amended and Restated Bylaws of the registrant (incorporated by reference to Exhibit 3.2 to the registrant’s Current Report on Form 8-K (file no. 0-26483), filed on November 5, 2010)

10.1*		Purchase Agreement, effective as of January 1, 2012, by and between diaDexus, Inc. and Health Diagnostics Laboratory

10.2*		Rebate Addendum, effective as of March 1, 2012, by and between diaDexus, Inc. and Health Diagnostics Laboratory

10.3		Offer Letter, dated January 8, 2012, by and between diaDexus, Inc. and Jean-Frédéric Viret (incorporated by reference to Exhibit 10.61 to the registrant’s Annual Report on Form 10-K (file no. 0-26483), for the fiscal year ended December 31, 2011, filed on March 15, 2012)

10.4		Stock Option Agreement, dated February 1, 2012, by and between diaDexus, Inc. and Jean-Frédéric Viret (incorporated by reference to Exhibit 10.62 to the registrant’s Annual Report on Form 10-K (file no. 0-26483), for the fiscal year ended December 31, 2011, filed on March 15, 2012)

10.5		Change in Control and Severance Agreement, dated February 2, 2012, by and between diaDexus, Inc. and Jean-Frédéric Viret (incorporated by reference to Exhibit 10.63 to the registrant’s Annual Report on Form 10-K (file no. 0-26483), for the fiscal year ended December 31, 2011, filed on March 15, 2012)

10.6		Amended and Restated Employment Agreement, effective as of March 1, 2012, by and between diaDexus, Inc. and Emilia Zychlinsky Bulaevsky

31.1		Certification of Chief Executive Officer pursuant to Exchange Act Rule 13a-14(a)

31.2		Certification of Chief Financial Officer pursuant to Exchange Act Rule 13a-14(a)

32.1		Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

32.2		Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

101.INS**		XBRL Instance Document



101.SCH**		XBRL Taxonomy Extension Schema Document

101.CAL**		XBRL Taxonomy Extension Calculation Linkbase Document

101.LAB**		XBRL Taxonomy Extension Label Linkbase Document

101.PRE**		XBRL Taxonomy Extension Presentation Linkbase Document

*	Certain portions have been omitted pursuant to a confidential treatment request. Omitted information has been filed separately with the SEC.

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