Accumetrics' VerifyNow P2Y12 Test receives CE mark approval for prognostic use

May 17 2011

Accumetrics, Inc., developer of the VerifyNow® System, the first rapid and easy-to-use point-of-care system for measuring platelet reactivity to multiple antiplatelet agents, announced today that the VerifyNow P2Y12 Test is now CE marked for prognostic use in identifying patients with high residual platelet reactivity (also termed poor responders) on antiplatelet therapy (e.g. clopidogrel) who are at greater risk for future cardiovascular events.

Numerous studies have demonstrated the link between high residual platelet reactivity and greater risk of ischemic events.  Studies comprising over 3,000 patients, utilizing the VerifyNow P2Y12 Test, have shown a correlation to clinical outcomes based on PRU (P2Y12 Reaction Units) results, concluding that an on-treatment PRU of greater than or equal to 230 identifies patients at significantly greater risk for future cardiovascular events including death, heart attack and stent thrombosis.  

"Researchers, such as myself, have long been studying the relationship between platelet reactivity while on antiplatelet therapy and the risk of recurrent ischemic events in our cardiovascular patients," stated Robert F. Storey, MD, Professor of Cardiology at the University of Sheffield, England.   "The VerifyNow P2Y12 Test offers a simple and rapid means of assessing an individual's response to antiplatelet medication.  The achievement of a prognostic claim will reinforce its application to risk stratification, potentially guiding therapy in patients undergoing coronary stenting."

"The CE mark for prognostic use of the VerifyNow P2Y12 Test in risk assessment represents a major milestone for Accumetrics," said Timothy I. Still, President and CEO of Accumetrics.  "Also considering the recent inclusion of platelet reactivity testing in both the ACCF/AHA UA/NSTEMI Guidelines and the STS/SCA Blood Conservation Guidelines, the VerifyNow System is making a significant impact on how physicians are treating their cardiovascular patients."

SOURCE Accumetrics, Inc.