The Food and Drug Administration (FDA) granted 510(k) clearance permitting marketing for Nanosphere Inc‘s 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.
In April 2011, the CYP2C19 Test received CE IVD Mark for commercial distribution in Europe, as well as all countries recognizing the CE Mark.
[Source: Nanosphere Inc]