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8-K - FORM 8-K - NANOSPHERE INC | c19017e8vk.htm |
Nanosphere, Inc.
4088 Commercial Avenue
Northbrook, IL 60062
4088 Commercial Avenue
Northbrook, IL 60062
NEWS
FOR IMMEDIATE RELEASE
FOR IMMEDIATE RELEASE
Nanosphere To Provide Additional Data to FDA for
Verigene Clopidogrel Metabolism Nucleic Acid Test
Verigene Clopidogrel Metabolism Nucleic Acid Test
NORTHBROOK, Ill., June 21, 2011 Nanosphere, Inc. (Nasdaq:NSPH) announced today it will provide
additional information for its premarket approval (PMA) application following the Food and Drug
Administrations (FDA) issuance of a not approvable letter for the Verigene Clopidogrel Metabolism
Nucleic Acid Test (Plavix Metabolism).
The Company believes the deficiencies cited in the FDA letter are resolvable and ultimately the PMA
for the Plavix Metabolism test will be approved by the FDA, although there can be no assurance of
such approval.
The issuance of the Letter means that the Company will encounter a delay in its plans to
commercialize this product in the United States. The initial U.S. revenue ramp from this product
will likely not commence until 2012, the Company said. The Plavix Metabolism test is CE IVD Marked
and currently being sold in certain European markets. The Company intends to launch the product in
additional European and Asian markets before the end of 2011.
About Nanosphere, Inc.
Nanosphere develops, manufactures and markets an advanced molecular diagnostics platform, the
Verigene® System, for multiplexed infectious disease, genetic, and ultra-sensitive protein testing.
This easy to use platform offers laboratories a convenient, simple, and cost-effective solution for
highly sensitive nucleic acid and protein testing. Nanosphere is based in Northbrook, IL.
Additional information is available at http://www.nanosphere.us.
Except for historical information, the matters discussed in this press release are forward-looking
statements and are subject to risks and uncertainties. Actual results could differ materially from
these forward-looking statements. Factors that could cause or contribute to such differences
include, but are not limited to, the following: (i) Nanospheres ability to develop commercially
viable products; (ii) Nanospheres ability to achieve profitability; (iii) Nanospheres ability to
produce and market its products; (iv) Nanospheres ability to obtain regulatory approval of its
products; (v) Nanospheres
ability to protect its intellectual property; (vi) competition and alternative technologies; and
(vii) Nanospheres ability to obtain additional financing, if and when necessary, to support its
operations. Additional risks are discussed in the Companys current filings with the Securities and
Exchange Commission. Although the Company believes the expectations reflected in such
forward-looking statements are based on reasonable assumptions, it can give no assurance that its
expectations will be attained. The forward-looking statements are made as of the date of this press
release, and we undertake no obligation to publicly update or revise any forward-looking statement,
whether as a result of new information, future events or otherwise.
Contact: |
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Investors:
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Media: | |
Nanosphere, Inc.
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The Torrenzano Group | |
Roger Moody, 847-400-9021
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Ed Orgon, 212-681-1700 | |
rmoody@nanosphere.us
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ed@torrenzano.com |