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Nanosphere Gets FDA OK for New Respiratory Virus Test

Oct 13, 2009

NEW YORK (GenomeWeb News) – Nanosphere today said that it has received US Food and Drug Administration clearance for its influenza A & B and respiratory syncytial virus test for its Verigene SP System.

The Verigene SP System is the firm's newer version of its first-generation Verigene System. It is an automated sample-to-result molecular diagnostic instrument.

"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," Nanosphere President and CEO William Moffitt said in a statement.

Nanosphere had previously said that it intends to submit additional FDA applications for each of its previously 510(k)-cleared assays — including a thrombophilia or hypercoagulation panel, a warfarin metabolism assay, and a cystic fibrosis panel — for use on the Verigene SP System.

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