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

April 16, 2013–Accumetrics, Inc. (San Diego, CA) announced an expansion in the intended use for the company's CE Mark-approved VerifyNow P2Y12 test. With the test results, physicians can assess whether a patient may be at greater risk for bleeding and 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 that validated the existence of a therapeutic window. The ADAPT-DES registry includes 8,500 patients using the VerifyNow system. 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,” commented Gilles Montalescot, MD, in Accumetrics' press release. Dr. Montalescot is 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 that we can use the information provided by the test to assess the bleeding risk of patients on treatment.”

According to the company, 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 Mark approval claim.

Ajay J. Kirtane, MD, presented these data at ACC.13, the 62nd annual scientific session of the American College of Cardiology in San Francisco, California. Dr. Kirtane is Chief Academic Officer of the Center for Interventional Vascular Therapy at Columbia University Medical Center/New York-Presbyterian Hospital in New York, New York. Dr. Kirtane also commented on the results in the company's announcement.

Dr. Kirtane stated, “Most prior analyses have focused upon platelet hyporesponsiveness as an established correlate of adverse ischemic events such as stent thrombosis. 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 overaggressive platelet inhibition, which can be measured through a point-of-care assay.”

Accumetrics stated that the addition of the therapeutic window claim marks the second major change to the CE Mark-approved intended use of the VerifyNow P2Y12 test in the last 2 years. With a similar claim currently being reviewed by the US Food and Drug Administration, Accumetrics stated that it is on track to have the first platelet reactivity test with a claim in the United States and the European Union to assess risk of both bleeding and ischemic events.

Accumetrics advised that its VerifyNow system is a rapid and easy-to-use platform to help physicians determine an individual's response to multiple antiplatelet agents. The VerifyNow P2Y12 test and the VerifyNow PRU test 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 United States for evaluating the risk of bleeding and the risk of recurrent ischemic events in cardiovascular patients.