FDA clears Nanosphere test for detecting CYP2C19 mutations affecting drug metabolism

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Nanosphere's CYP2C19 nucleic acid test to determine gene variants affecting drug metabolism.

The CYP2C19 enzyme, in general, metabolizes approximately 15% of all prescribed drugs, while variations in the CYP2C19 gene that code for the enzyme may lead to individual differences in drug metabolism.

The test, which is designed for use on the automated sample-to-result Verigene system, identifies CYP2C19 *2, *3 variants that account for the majority of reduced drug metabolism as well as *17 variant associated with increased drug metabolism.

Using patient’s whole blood sample, the test provides results in less than 2.5 hours, according to the company.

Nanosphere chief executive officer William Moffitt said the crucial information provided from the test will help physicians to treat patients quickly and appropriately with the most effective drugs.

"This achievement adds to our growing menu of FDA-cleared assays, which includes tests for gram positive bloodstream infections (BC-GP), respiratory viruses (RV+), hypercoagulation, and warfarin metabolism," Moffitt added.