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8-K - WaferGen Bio-systems, Inc. | v177044_8k.htm |
Exhibit
99.1
March
10, 2010
FOR
IMMEDIATE
RELEASE
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|
Contact:
WaferGen
Mona
Chadha
510-651-4450
Mona.Chadha@WaferGen.com
|
WaferGen
Announces Eight New Early-Access Customers;
Ships
First International SmartChip System Following CE Certification
Company’s
commercialization strategy to generate revenue through early access program and
service prior to general availability
Fremont, Calif., March 10,
2010 – WaferGen Biosystems, Inc. (OTCBB:WGBS), a leading developer of
state-of-the-art genetic analysis systems, today announced eight new
early-access customers that include major universities and service providers in
the U.S. and Japan. The company also announced that it has shipped the first
SmartChip Real-Time PCR System to an international customer following CE marking
certification. WaferGen’s commercialization strategy is to generate
revenue through the early-access program and the recently launched service prior
to broader availability of the SmartChip System planned for later this
year.
The new
early-access customers include Stanford University, University of California at
San Francisco, University of Pittsburgh, University of Southern California
(USC), the University of Texas Southwestern, two Japanese organizations, and an
undisclosed U.S. biotech company. The first international shipment
was made to an organization in Japan. Research underway at these
organizations includes applications for lung disease, wound healing, stem cell
research and oncology.
“These
notable early users of our SmartChip platform are clear indication of its value
to vastly improve gene expression analysis and genotyping in order to provide a
better understanding of disease at the molecular level and advance the drug
development process,” said Alnoor Shivji, WaferGen chief executive officer,
president, and chairman.
“SmartChip
offers researchers the high-throughput capability of interrogating thousands of
genes and validating hundreds of samples simultaneously in a single run using
Real-Time PCR. This improved molecular analysis could thereby provide
the potential for a patient to be diagnosed and even selected for clinical
trials according to genetic information. Therapies could be developed to work on
specific molecular targets. This could shorten the drug development
process, help reduce the costs of drug development, and enable more successful
end-products.”
“The CE
Marking certification of our SmartChip Cycler and SmartChip Nanodispenser will
enable us to market and sell the SmartChip system in Europe and Japan where the
CE mark is recognized,” said Shivji. “This certification along with the TUV
safety approval for North America represents significant steps in our process
toward commercialization.”
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The CE Marking is verification that medical devices have met specified health, safety and environmental protection requirements allowing them to gain access to the EU market.
Three of
the new customers have signed agreements to use the WaferGen SmartChip Service
to receive gene-expression profiling services by WaferGen scientists at the
company’s new headquarters facility in Fremont, Calif. The
WaferGen SmartChip Service is targeted at scientists involved in the discovery
and validation of molecular biomarkers, which are gene expression
patterns. By comparing biomarkers of normal and diseased
patients in the presence or absence of drugs, scientists have better insight
into the genes or set of genes that can be used in drug
development.
The
remaining new customers are part of WaferGen’s early access program and have
earlier versions of the SmartChip System; shipments have already occurred,
including to the Japanese customers. They will be able to use the
SmartChip platform as part of their molecular research to enable accurate,
highly sensitive, high-throughput gene expression data. “These
customers gain early access to the benefits of SmartChip while we receive
revenue prior to general availability,” said Shivji.
The
WaferGen SmartChip System
The
SmartChip Cycler and the SmartChip Nanodispenser that received the CE/TUV
certification are two of three components of the SmartChip Real-Time PCR System
that also includes the SmartChip. The SmartChip contains 5184
nanowells preloaded with primer content optimized for performance with the
SmartChip System. The SmartChip Nanodispenser is used to dispense the
sample and master mix onto the SmartChip under vacuum in a specially designed
fixture and vacuum chamber. The dispensed chip is placed into the
specially designed WaferGen SmartChip Cycler and subjected to Real-Time PCR and
amplicon melting analyses. Data in the form of Ct (threshold cycles) and Tm
(melting temperatures) are downloaded and analyzed. Combined, the SmartChip
Real-Time PCR System is expected to provide industry-leading throughput levels,
while offering discovery and validation capability in a single platform.
The result will be the ability to conduct gene expression research at a fraction
of the time and cost currently produced by existing instrument
systems.
The
WaferGen SmartChip Service
The
initial product run on the SmartChip platform as part of the WaferGen SmartChip
Service is the SmartChip Human Oncology Gene Panel that provides pathway based
gene expression profiling for Oncology. Recently made available as part of the
service is the Human microRNA Panel that provides the most comprehensive human
microRNA panel of more than 800 microRNAs on a single SmartChip. MicroRNAs are
small non-protein-coding single-stranded RNA molecules that function as negative
regulators of gene expression by targeting specific messenger RNAs that could
benefit diagnosis, prognosis, and treatment of diseases such as
cancer.
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About WaferGen and the SmartChip Real-Time PCR System
WaferGen
Biosystems, Inc. is a leader in the development, manufacture and sale of
state-of-the-art systems for genetic analysis for the life science and
pharmaceutical industries. The company is actively developing its
SmartChip product for the gene expression and genotyping markets. The
SmartChip Real-Time PCR System is designed as the first whole genome,
high-throughput gene expression real-time PCR platform. Combined with
next-generation chemistry and optimized assays being developed by WaferGen under
the guidance of David Gelfand, Ph.D., Chief Scientific Officer and one of the
pioneers of PCR, this innovative system promises to deliver significant speed
and cost advantages to researchers in the gene expression and genotyping
markets.
Based on
collaborations established with leading research institutions, WaferGen believes
that the SmartChip Real-Time PCR System is positioned as the platform of choice
for biomarker discovery and validation. The system will provide a number of key
ease-of-use features including content-ready chips with gene panels optimized
for microRNA, cancer, and whole genome. WaferGen believes the SmartChip
Real-Time PCR System will be the first platform to combine the high-throughput
capability and cost efficiencies of existing microarrays, with the sensitivity
and accuracy of real-time PCR.
Forward-Looking
Statements
This
press release contains certain "forward-looking statements". Such
statements include statements relating to the expected benefits and advantages
of the SmartChip service for gene-expression research, the expected benefits and
advantages of the SmartChip technology to other applications, the expected
throughput levels of the SmartChip Real-Time PCR System and other statements
relating to future events or to the company’s future financial performance and
are not historical facts, including statements which may be preceded by the
words "intends," "may," "will," "plans," "expects," "anticipates," "projects,"
"predicts," "estimates," "aims," "believes," "hopes," "potential" or similar
words.
Forward-looking
statements are not guarantees of future performance, are based on certain
assumptions and are subject to various known and unknown risks and
uncertainties, many of which are beyond the control of the
company. Actual results may differ materially from the expectations
contained in the forward-looking statements. Factors that may cause
such differences include the risks that: (i) the company may be unsuccessful in
commercially developing its products or in achieving market acceptance of new
and relatively unproven technologies; (ii) the company will need to raise
additional capital to meet its business requirements in the future and the
company may not be able to do so on reasonable terms or at all; (iii) the
company’s proprietary intellectual property rights may not adequately protect
its products and technologies; and (iv) the company expects intense competition
in its target markets, including from companies that have much greater resources
than the company, and there can be no assurance that the company will be able to
compete effectively. More detailed information about the company and the
risk factors that may affect the realization of forward-looking statements is
set forth in the company’s filings with the Securities and Exchange Commission,
including the company’s Annual Report on Form 10-K for the year ended December
31, 2008 and the company’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 2009. Investors and security holders are urged to read this
document free of charge on the SEC's web site at www.sec.gov. The
company does not undertake to publicly update or revise its forward-looking
statements as a result of new information, future events or
otherwise.
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The
information stated above was prepared by WaferGen BioSystems, Inc. and reflects
solely the opinion of WaferGen. Nothing in this statement shall be construed to
imply any support or endorsement of WaferGen, or any of its products, by The
Regents of the University of California, its officers, agents and
employees.
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