Accumetrics VerifyNow P2Y12 Test Receives CE Mark Approval for Prognostic Use

May 17, 2011—Accumetrics, Inc. (San Diego, CA) announced that the company's VerifyNow P2Y₁₂ test received CE Mark approval for prognostic use in identifying patients with high residual platelet reactivity on antiplatelet therapy who are at a greater risk for future cardiovascular events. The company advised that the VerifyNow P2Y₁₂ test is not currently indicated for use in risk assessment in the United States.

The company noted that numerous studies have shown the link between high residual platelet reactivity and a greater risk of ischemic events.

According to Accumetrics, studies comprising more than 3,000 patients utilizing the VerifyNow P2Y₁₂ test have shown a correlation to clinical outcomes based on P2Y₁₂ Reaction Units results, concluding that an on-treatment P2Y₁₂ Reaction Units of ≥ 230 identifies patients who are at a 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,” commented Robert F. Storey, MD. “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.”