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Posted in | Nanomedicine | Nanobusiness

Nanosphere Receives 510(k) Clearance from the FDA

Published on October 13, 2009 at 7:18 AM

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.

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