Accumetrics Obtains CE Mark for Therapeutic Window Claim on the VerifyNow P2Y12 Test

  Accumetrics Obtains CE Mark for Therapeutic Window Claim on the VerifyNow
  P2Y12 Test

 New claim will help physicians better guide treatment with P2Y12 inhibitors

Business Wire

SAN DIEGO -- April 16, 2013

Accumetrics, Inc., developer of the market-leading VerifyNow^® System,
announced an expansion in the intended use for the CE marked VerifyNow P2Y12
Test. Physicians can now use the test results to assess whether a patient may
be at greater risk for both bleeding or ischemic events, as an aid to manage
therapeutic treatment decisions and accurately assess the antiplatelet effect
from P2Y12 inhibitors (such as clopidogrel, prasugrel and ticagrelor).

The expanded claim was developed based on the ADAPT-DES registry (8500
patients using the VerifyNow system), which validated the existence of a
therapeutic window. The data demonstrated that patients with a P2Y12 Reaction
Units (PRU) result of ≥208 were at a significantly increased risk of
cardiovascular events and patients with a PRU of <95 were receiving virtually
no additional protection from cardiovascular events, but at a significantly
increased risk of bleeding.

“Balancing efficacy and safety is one of the most critical choices we need to
make when selecting a P2Y12 inhibitor for long-term use in our patients,” said
Dr. Gilles Montalescot, MD, PhD, Professor of Cardiology for the Institut de
Cardiologie at Hospital la Pitié-Salpêtrière in Paris, France. “In the ARCTIC
study, we saw signs that a platelet reactivity guided strategy may result in
less bleeding. This association was found in ADAPT-DES and suggests thatwe
can use the information provided by the test to assess the bleeding risk of
patients on treatment."

Previous studies have demonstrated the association between PRU and increased
risk for recurrent ischemic and bleeding events. However, most of those
studies were too small to warrant a label change for the VerifyNow P2Y12 Test.
With the large number of patients, and real-world patient population
represented in ADAPT-DES, there was significant evidence to proceed with a CE
marked claim.

“Most prior analyses have focused upon platelet hyporesponsiveness as an
established correlate of adverse ischemic events such as stent thrombosis,”
stated Dr. Ajay J. Kirtane, MD, SM,Chief Academic Officer of the Center for
Interventional Vascular Therapy at Columbia University Medical Center /
NewYork-Presbyterian Hospital in New York City, who presented these data at
ACC.13. “In this analysis from ADAPT-DES, the demonstration of increased
bleeding events at the lowest levels of on-treatment platelet reactivity –
independent of other baseline characteristics – suggests that there may be a
price to pay for over-aggressive platelet inhibition, which can be measured
through a point-of-care assay."

The addition of the therapeutic window claim marks the second major change to
the intended use of the CE marked VerifyNow P2Y12 Test in the last two years.
With a similar claim currently being reviewed by the FDA, Accumetrics is on
track to have the first platelet reactivity test with a claim in the U.S. and
the EU to assess risk of both bleeding and ischemic events.

“The achievement of this new CE marked claim is a very positive step forward
for the VerifyNow System and the entire field of platelet reactivity testing,”
said Timothy Still, President and CEO of Accumetrics. “The expanded claims
will provide greater clarity on how to interpret the VerifyNow P2Y12 and PRU
Test results, which will enable an improved quality of care for the millions
of patients on antiplatelet therapies.”

The VerifyNow System is currently used in over 1000 facilities in the United
States and over 80 countries worldwide where antiplatelet medications are
prescribed to reduce the occurrence of future thrombotic events such as heart
attack and stroke. Platelet reactivity testing is already included in the
following guidelines: European Society of Cardiology NSTE-ACS, ACC/AHA
UA/NSTEMI, ACC/AHA/SCAI PCI and Society of Thoracic Surgeons Use of
Antiplatelet Drug in Patients Having Cardiac and Non-Cardiac Surgery.

About Accumetrics

Accumetrics is committed to advancing medical understanding of platelet
function and enhancing quality of care for patients receiving antiplatelet
therapies by providing industry-leading and widely accessible diagnostic tests
for rapid platelet function assessment.

Accumetrics’ VerifyNow System is the first rapid and easy-to-use platform to
help physicians determine an individual’s response to multiple antiplatelet
agents. Addressing every major antiplatelet drug, including FDA-cleared
products for aspirin, P2Y12 inhibitors (e.g. clopidogrel) and GP IIb/IIIa
inhibitors, the VerifyNow System provides valuable information to help
physicians make informed clinical decisions. The VerifyNow P2Y12 Test and the
VerifyNow PRUTest are whole blood assays used in the laboratory or point of
care setting to measure the level of platelet P2Y12 receptor blockade.
Additionally, the VerifyNow P2Y12 Test is indicated outside the U.S. for
evaluating the risk of bleeding and the risk of recurrent ischemic events in
cardiovascular patients.

For more information about the Company and its products, visit
www.accumetrics.com.

The Accumetrics logo and VerifyNow are registered trademarks of Accumetrics,
Inc.

Contact:

Jakob Jakobsen
310-309-1003 (Office)
310-409-5351 (Cell)
jjakobsen@biosector2.com
or
Timothy I. Still
President and CEO
Accumetrics
858-404-8260
press@accumetrics.com
 
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