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New test for aspirin resistance gets FDA waiver

Physician Practice Advisor, March 30, 2005

Current estimates show 25 million people taking daily doses of aspirin as a
preventitive measure to combat the risk of heart attack and stroke. However, published research has indicated that up to 30% of patients' bodies fail to fully respond to aspirin, leading to a condition known as "aspirin resistance."

On March 17, San Diego-based company Accumetrics announced that its new product, the VerifyNowT Aspirin Test, received a waiver from the Food and Drug Administration (FDA) under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). This will allow more than 50,000 physician offices across the country the opportunity to perform a simple rapid blood test on patients to whom they prescribe daily doses of aspirin.

The test identifies "aspirin resistance" in patients by measuring the degree to which a patient's blood platelets aggregate in response to aspirin. Depending on the number of Aspirin Reaction Units found with the test, the patient is found either to be receiving the full benefits of aspirin or unresponsive and therefore at higher risk for a cardiac event. In that event, recommended treatment options include changing the aspirin dosage or substituting in another antiplatelet agent.

The VerifyNow Aspirin test takes roughly 30 minutes to deliver results and is covered under medical insurance and Medicare plans. More information on the test is available at http://www.accumetrics.com.

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