Ottawa, Ontario --Spartan Bioscience today announced data from the RAPID GENE study showing that point-of-care DNA testing successfully identified patients carrying the CYP2C19*2 gene at the time of cardiac catheterization. Cardiologists were then able to prescribe antiplatelet therapy according to the patient’s genotype. This personalized medicine approach completely eliminated high on-treatment platelet reactivity (HPR) in CYP2C19*2 carriers.

RAPID GENE is the first randomized prospective clinical trial to demonstrate the utility of point-of-care DNA testing for personalized medicine. Data from the study were presented today in a late-breaking clinical trial session at the 2011 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.

The RAPID GENE study enrolled 200 patients who were being treated with cardiac stenting for an acute coronary syndrome or stable angina. Patients were randomized to a treatment strategy of rapid point-of-care genotyping and Effient® (prasugrel) for CYP2C19*2 carriers, or to standard therapy with Plavix® (clopidogrel). The Spartan RX CYP2C19 point-of-care DNA test was performed by nurses who received a 30-minute training session, but had no prior laboratory training. The test had a sensitivity of 100% and a specificity of 99.4% compared with DNA sequencing. For CYP2C19*2 carriers, treatment with prasugrel completely eliminated HPR. In contrast, 30.4% of carriers receiving clopidogrel had HPR at 1 week.

“RAPID GENE has demonstrated the feasibility of rapid genotyping and personalized antiplatelet therapy,” said Derek So, M.D., F.R.C.P., Interventional Cardiologist at the University of Ottawa Heart Institute (UOHI). “For the first time, nurses were able to perform DNA testing at the patient’s bedside.” Dr. So served as principal investigator of the RAPID GENE trial, and presented the RAPID GENE data during the late-breaking clinical trial session at TCT.

"These results demonstrate the power of point-of-care DNA testing,” said Larry D’Andrea, CEO, Spartan Bioscience. “Spartan’s technology is helping fulfill the promise of personalized medicine.”

Source: PRWeb