Nanosphere, Inc. (NSPH) Receives FDA Clearance to Market the Verigene CYP2C19 Test
Nanosphere, a leading provider of advanced molecular diagnostics systems, announced that the U.S. Food and Drug Administration has granted 510(k) clearance, permitting the marketing of the company’s CYP2C19 Nucleic Acid Test on the automated sample-to-result Verigene System. The Verigene CYP2C19 Test is indicated as an aid to help clinicians determine therapeutic strategy for drugs metabolized by the CYP450 2C19 genetic pathway. In less than 2.5 hours, the Verigene CYP2C19 Test identifies the CYP2C19 *2, *3, and *17 variations, if present, directly from a patient’s whole blood sample. The test gives physicians the crucial information they need to treat patients quickly…