New CE Marked Prognostic Claim for the VerifyNow Test


June 3, 2011

June 3, 2011 – European CE mark approval was granted to expand use of the VerifyNow point-of-care P2Y12 test platelet reactivity test to identify patients who are poor-responders to antiplatelet therapy (e.g. clopidogrel).

Numerous studies have demonstrated the link between high residual platelet reactivity and greater risk of ischemic events. Studies comprising more than 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 equal to or greater than 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, M.D., 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 VerifyNow system is widely used in various clinical settings where antiplatelet medications are prescribed to reduce the occurrence of future thrombotic events such as heart attack and stroke. It is not currently indicated for use in risk-assessment in the United States. CE marking of this use is recognized in the European Economic Area.

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