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Nanosphere Submits Application to FDA for Respiratory Virus Assay

NEW YORK (GenomeWeb News) – Nanosphere today said that it has filed a 510(k) application to the US Food and Drug Administration for marketing clearance of its Verigene SP Respiratory Virus Assay.

The assay detects influenza and respiratory syncytial virus and runs on the firm's Verigene SP system, an automated sample-to-result molecular diagnostic instrument. The Verigene SP is a newer version of the firm's first-generation Verigene system.

"The market has strongly signaled its need for a flu test that provides greater sensitivity than currently available rapid tests, combined with optimized ease of use and turnaround time not found in either traditional culture methods or the currently available molecular tests," Nanosphere President and CEO William Moffitt said in a statement. "Our respiratory panel running on the Verigene SP directly addresses these market needs."

The firm also noted 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.

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