ARTICLE | Clinical News

Spartan RX CYP2C19: Phase II/III data

April 2, 2012 7:00 AM UTC

The open-label, Canadian Phase II/III RAPID GENE trial in 187 patients showed that Spartan's Spartan RX CYP2C19 test had 100% sensitivity and 99.3% specificity for identifying carriers of CYP2C19 mutations, which may affect the efficacy of cardiovascular drug Plavix clopidogrel. The trial enrolled patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) or stable angina to be randomly assigned to rapid point-of-care genotyping for CYP2C19 mutations with the Spartan RX CYP2C19 test or standard treatment. Patients identified as carriers of at least 1 CYP2C19 mutation received once-daily Effient prasugrel plus aspirin, while non-carriers and patients in the standard treatment group received once-daily Plavix plus aspirin. Of the 23 carriers in the rapid genotyping group, none had a high on-treatment platelet reactivity of >234 P2Y12 reaction units (PRU) at day 7 vs. 30% of patients receiving standard treatment (p=0.0092). Data were published in The Lancet. ...