'Not Approvable' Letter Thwarts Nanosphere's Hopes to Launch FDA-Approved Plavix PGx Test | GenomeWeb

Originally published June 21.

This article has been updated on June 22 with comments from a Nanosphere official and analyst quotes.

By Turna Ray

Following a negative decision from the US Food and Drug Administration on a premarket approval application for its Verigene CYP2C19 Plavix Metabolism Test, Nanosphere said it will delay the commercialization of the test in the US.

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