Nanosphere Announces FDA Submission of 510(k) Documentation for Its Verigene Cardiac Troponin I Assay


NORTHBROOK, Ill., Nov. 18, 2009 (GLOBE NEWSWIRE) -- Nanosphere, Inc. (Nasdaq:NSPH), a leader in the development and commercialization of advanced molecular diagnostics systems, announced today it submitted a 510(k) application to the FDA for its cardiac troponin I test that the company believes will provide early and sensitive diagnosis of myocardial infarction and risk stratification for acute coronary syndromes.

"We are pleased to submit this application and look forward to completing the regulatory process and bringing this important assay to market," said William Moffitt, Nanosphere's president and chief executive officer. Mr. Moffitt added, "There is growing evidence that early detection of cardiac troponin using sensitive assays is a critical test to aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndrome."

About Nanosphere, Inc.

Nanosphere develops, manufactures and markets an advanced molecular diagnostics platform, the Verigene(R) System, for multiplexed direct genomic and ultra-sensitive protein detection. This easy to use platform offers laboratories a convenient, simple, and cost effective solution for highly sensitive genomic and protein testing. Nanosphere is based in Northbrook, IL. Additional information is available at http://www.nanosphere.us.

The Nanosphere, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=4344

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) Nanosphere's ability to develop commercially viable products; (ii) Nanosphere's ability to achieve profitability; (iii) Nanosphere's ability to produce and market its products; (iv) Nanosphere's ability to obtain regulatory approval of its products; (v) Nanosphere's ability to protect its intellectual property; (vi) competition and alternative technologies; and (vii) Nanosphere's ability to obtain additional financing, if and when necessary, to support its operations. Additional risks are discussed in the Company's 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.



            

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