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New CE Marked Prognostic Claim for the VerifyNow P2Y12 Test

May 16, 2011 By Bio-Medicine.Org

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 m

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SOURCE

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