Healthcare Industry News: RSV
News Release - January 13, 2011
Nanosphere Receives FDA Clearance for Respiratory Virus Subtyping Test PanelNORTHBROOK, Ill., Jan. 13, 2011 -- (Healthcare Sales & Marketing Network) -- Nanosphere, Inc. (Nasdaq:NSPH ), a leader in the development and commercialization of advanced molecular diagnostics systems, announced today FDA 510(k) clearance for the Verigene(R) Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene(R) System.
The RV+ test expands Nanosphere's existing test capabilities for the detection of respiratory viruses. In a single test, the RV+ provides Influenza A, Influenza B, RSV A, and RSV B detection, and further subtypes Influenza A as H1, H3, or 2009 H1N1.
"This timely clearance of RV+ will let Nanosphere offer customers the broadest respiratory virus panel available in the market on a sample-to-result platform," said William Moffitt, Nanosphere's president and chief executive officer. "Moreover, the RV+ test's clearance enables molecular respiratory testing to begin moving into mainstream medicine."
The RV+ automates the steps of viral RNA extraction, multiplexed RT-PCR amplification, and target detection on the Verigene(R) System and requires only a single pipetting step. Operationally similar, Nanosphere's existing respiratory assay cleared on the same Verigene(R) System received a CLIA categorization of "moderate complexity."
The RV+ test does not contain the recommendation to confirm all negative results with culture-based detection methods. Additionally, the random access, rapid turn-around time, and ease-of-use attributes allow any hospital to benefit from the high sensitivity and specificity of molecular testing without sacrificing the convenience and accessibility of rapid testing.
About Nanosphere, Inc.
Nanosphere develops, manufactures and markets an advanced molecular diagnostics platform, the Verigene(R) 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) 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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