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FDA Declines Clearance of Nanosphere PMA for Plavix Metabolism Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Nanosphere today said that it has received a not approvable letter from the US Food and Drug Administration for its Verigene Clopidogrel Metabolism Nucleic Acid Test.

Shares of Nanosphere dropped 24 percent to $1.69 in early Tuesday trade on the Nasdaq.

The Northbrook, Ill.-based molecular diagnostics firm had filed a premarket approval application with FDA for the test, which aims to evaluate whether a patient is successfully metabolizing the anti-platelet drug Plavix (clopidogrel). It received the not approvable letter on June 9, 2011, from the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) in the Center for Devices and Radiological Health.

Nanosphere said that it believes the deficiencies cited in the letter from the FDA are resolvable, and it believes that the test will ultimately gain clearance from the agency, "although there can be no assurance of such approval."

As a result of the delay, Nanosphere said it isn't likely to report revenues from the test in the US until 2012. The Plavix Metabolism test has the CE IVD Mark and is sold in certain European countries already. The firm expects to launch the test in additional European and Asian markets before the end of 2011.