The European Union (EU) has granted Accumetrics’ VerifyNow P2Y12 test, a point-of-care system to measure platelet reactivity, a CE mark for use in Europe.
VerifyNow is used to help identify patients who are poor responders to antiplatelet therapy including prasugrel (Effient, Daiichi Sankyo/Eli Lilly) and clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis), among other agents.
The San Diego-based company said that previous studies have shown a link between high platelet reactivity and increased ischemic events. This includes a study enrolling more than 3,000 patients that showed that high platelet reactivity increased a patients’ risk of death, MI and stent thrombosis.
While VerifyNow is being used in the clinical setting to help reduce the occurence of thrombotic events in nonresponders, the test is not indicated for use in risk assessment in the U.S.