Healthcare Industry News:  influenza 

Diagnostics FDA

 News Release - October 13, 2009

Nanosphere Announces FDA 510(k) Clearance of the Verigene(R) SP and Respiratory Virus Nucleic Acid Test

NORTHBROOK, Ill., Oct. 13, 2009 -- (Healthcare Sales & Marketing Network) -- Nanosphere, Inc. (Nasdaq:NSPH ), a leader in the development and commercialization of advanced molecular diagnostics systems, announced today it has received 510(k) clearance from the FDA for its influenza A & B and respiratory syncytial virus (RSV) test and the Verigene SP System, with complete sample-to-result automation.

"We are very pleased to receive clearance to provide our customers a better performing and easier to use solution for diagnosing influenza and RSV viruses in time for this flu season," said William Moffitt, Nanosphere's president and chief executive officer. Mr. Moffitt added, "The attention drawn to this flu season has highlighted the need for a respiratory virus test that offers better sensitivity than the rapid strip tests and faster and easier testing than cultures or currently available molecular tests. Our assay addresses these needs and demonstrates the power and flexibility of the Verigene System. Nanosphere's respiratory virus assay run on the Verigene SP platform provides clinicians with the first sample-to-result system that combines the benefits of high sensitivity and specificity with ease of use and rapid turn-around time."

The Verigene SP provides automated sample-to-result molecular diagnostics capabilities in a multiplexed, random-access, modular system utilizing the same imaging technology as the first generation Verigene, allowing for complementary or stand alone integration into both molecular and microbiology laboratories.

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.

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.


Source: Nanosphere

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