This article is more than 5 years old. Information may no longer be current.
RAPID GENE: Genetic test identifies presence of common genetic variant
Click Here to Manage Email Alerts
A new point-of-care genetic test successfully identified the presence of a common genetic variant associated with increased rates of major adverse events in individuals given clopidogrel after percutaneous coronary intervention.
Researchers enrolled 200 patients in the prospective, randomized, proof-of-concept RAPID GENE study. Patients undergoing PCI for acute coronary syndromes or stable angina were randomly assigned to rapid point-of-care genotyping to screen for the CYP2C19*2allele or to standard treatment. Carriers of the allele were administered 10 mg prasugrel daily; noncarriers and patients in the standard treatment group were administered 75 mg clopidogrel daily.
The researchers reported data on 91 patients in the rapid genotyping group and 96 in the standard treatment group. Twenty-three patients in each group carried at least one CYP2C19*2 allele.
The primary endpoint was the proportion of CYP2C19*2 carriers with high on-treatment platelet reactivity (P2Y12 reactivity unit >234) after 1 week of dual antiplatelet therapy. None of the 23 carriers in the rapid genotyping group had a PRU value >234 at 1 week compared with seven (30%) in the standard treatment group.
The test had a sensitivity of 100% and a specificity of 99%.
“For the first time in clinical medicine we have proven that a simple bedside test can enable rapid genetic testing and subsequent personalized therapy. This is an important step towards integrating pharmacogenomic strategies into clinical care,” Derek Y.F. So, MD, said in a press release.
The point-of-care test (Spartan RX CYP2C19, Spartan Biosciences) utilizes a buccal swab to test for the CYP2C19*2 allele. The bedside technology enables health care professionals with no previous training in genetic laboratory techniques to undergo genotyping, according to a press release.
“Our findings suggest that personalization of antiplatelet therapy might reduce adverse ischemic outcomes; use of prasugrel only in high-risk individuals might also minimize adverse bleeding events,” the researchers concluded.
In a commentary also published in The Lancet, Amber L. Beitelshees, PharmD, MPH, of the department of medicine at University of Maryland School of Medicine, said, “The RAPID GENE study provides much-needed impetus by showing that genotyping can be done in a timely manner and incorporated into the clinical workflow as we wait for the results of large outcome-driven randomized trials.”
For more information:
- Beitelshees AL. Lancet. 2012;doi:10.1016/S0140-6736(12)60431-0.
- Roberts JD. Lancet. 2012;doi:10.1016/S0140-6736(12)60161-5.
Disclosure: Dr. So has received unrestricted research grants for physician-initiated studies from Abbott Vascular, Sanofi-Aventis and Spartan Biosciences, and honoraria from Eli Lilly. The other researchers and Dr. Beitelshees report no relevant financial disclosures. The RAPID GENE study was funded by Spartan Biosciences.