Nanosphere, Inc. (Nasdaq:NSPH), a leader in the development and commercialization of advanced molecular diagnostics systems, announced today the US Food and Drug Administration (FDA) granted 510(k) clearance permitting marketing of its CYP2C19 Nucleic Acid Test (CYP2C19 Test) on the automated sample-to-result Verigene® System.
The Verigene CYP2C19 Test is indicated as an aid for clinicians to determine therapeutic strategy for drugs metabolized by the CYP450 2C19 genetic pathway. The Verigene CYP2C19 Test identifies the CYP2C19 *2, *3, and *17 variations, if present, directly from a patient's whole blood sample in less than 2.5 hours.
"The Verigene CYP2C19 Test provides physicians with crucial information to help treat patients quickly and appropriately with the most effective drugs," said William Moffitt, Nanosphere's chief executive officer. "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."
The Verigene System is a molecular diagnostics platform capable of performing tests for genetic, infectious disease and protein targets on a single sample-to-result platform. The system's ease of use and on-demand processing capability enable hospitals to generate time-critical results in a near-patient setting.
In April 2011, the CYP2C19 Test received CE IVD Mark for commercial distribution in Europe, as well as all countries recognizing the CE Mark.
The CYP2C19 enzyme metabolizes approximately 15% of all prescribed drugs1 and is involved in the metabolism of several important drug classes, including, but not limited to, anti-depressants (amitriptyline), anti-platelet therapies (clopidogrel), anti-epileptics (phenytoin) and proton pump inhibitors (lansoprazole) 2,3,4. Variations in the CYP2C19 gene that code for the enzyme may lead to individual differences in drug metabolism. Two variants, *2 and *3 account for the majority of reduced drug metabolism while the *17 variant is associated with increased drug metabolism. The frequency of these variations in a patient's CYP2C19 gene varies based on the patient's ethnicity; ranging from 15% to 60% in Caucasian and Pacific Ocean populations respectively for the *2 variant, 8% to 15% in Asian and Pacific Ocean populations for the *3 variant, and 16% to 18% in African-American and Caucasian populations respectively for the *17 variant5.