NEW YORK (GenomeWeb News) – Nanosphere today said that the US Food and Drug Administration has cleared for marketing its CYP2C19 test to run on the firm's Verigene System.
The Verigene CYP2C19 Test was cleared as an aid to physicians in determining therapeutic strategy for drugs metabolized by the CYP450 2C19 genetic pathway. It identifies the CYP2C19 *2, *3, and *17 variations from a whole blood sample in less than 2.5 hours, said Nanosphere.
"This achievement adds to our growing menu of FDA-cleared assays, which includes tests for gram positive bloodstream infections, respiratory viruses, hypercoagulation, and warfarin metabolism," Nanosphere CEO William Moffitt said in a statement.
The test received the CE IVD Mark last year for distribution in Europe and other countries recognizing the CE Mark.