New CE Marked Prognostic Claim for Accumetrics, Inc.'s VerifyNow P2Y12 Test
Published: May 17, 2011
SAN DIEGO, May 17, 2011 /PRNewswire/ -- 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."
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. The VerifyNow P2Y12 Test 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.
Accumetrics is committed to enhancing quality of care for patients receiving antiplatelet therapies by providing widely accessible diagnostic tests for rapid assessment of platelet reactivity. The VerifyNow brand is the most widely studied and recognized brand in the field of platelet reactivity.
Accumetrics' VerifyNow System helps physicians determine an individual's platelet response to multiple antiplatelet agents. Addressing every major antiplatelet drug including aspirin, P2Y12 inhibitors (e.g. prasugrel (Effient®) and clopidogrel (Plavix®)), and GP IIb/IIIa inhibitors (e.g. ReoPro® and Integrilin®), the VerifyNow System provides valuable information to help physicians make informed treatment decisions. For more information about the Company and its products, visit www.accumetrics.com.
The Accumetrics logo and VerifyNow are registered trademarks of Accumetrics, Inc. ReoPro is a registered trademark of Eli Lilly and Co. Integrilin is a registered trademark of Millennium Pharmaceuticals. Plavix is a registered trademark of sanofi-aventis. Effient is a registered trademark of Eli Lilly and Company.
Timothy I. Still
President and CEO
SOURCE Accumetrics, Inc.