Transgenomic Announces Medicare Coverage for Clopidogrel Response Test


July 26, 2012

July 26, 2012 — Transgenomic Inc. has announced that National Government Services, the designated Medicare fiscal intermediary in Connecticut, has confirmed coverage for its proprietary Clopidogrel Genetic Absorption Activation Panel (C-GAAP, formerly PGxPREDICT: Clopidogrel). As a result of this coverage, the 48 million Americans currently covered by Medicare will have access to this genetic test. The C-GAAP is a clinically validated diagnostic test that identifies patients with genetic variations in CYP2C19, a gene whose effect is described in clopidogrel’s label, and ABCB1, a gene that is unique to Transgenomic’s panel and is covered by issued and pending patents owned by Transgenomic.

The effectiveness of clopidogrel, the most widely prescribed antiplatelet drug used to reduce the risks of heart attack, stroke and death, is dependent on a patient’s ability to absorb the drug through their intestine and then activate the drug by enzymes produced in the liver. Two genes, ABCB1 and CYP2C19, encode proteins critical for this absorption and activation. Patients with dysfunctional CYP2C19 and ABCB1 genes treated with clopidogrel exhibit a 50 percent increase in major adverse cardiovascular event rates than do patients with normal CYP2C19 and ABCB1 genetic function. The seriousness of this problem prompted the U.S. Food and Drug Administration (FDA) to add a black box warning to clopidogrel’s label in 2010 to alert physicians and patients about this cardiac risk and the usefulness of genetic testing in guiding treatment strategies. Subsequently, professional medical societies, including the American College of Cardiology and the American Heart Association, have issued practice guidelines recommending the consideration of genetic testing for patients at high-risk for poor clinical outcomes.

Transgenomic’s C-GAAP is a simple saliva test that identifies patients who cannot completely absorb or activate clopidogrel due to reduced function of CYP2C19 or ABCB1. C-GAAP analyzes markers in both genes to identify patients who are at a genetically increased risk of major adverse cardiovascular events due to diminished effectiveness of clopidogrel. Approximately 50 percent of patients taking clopidogrel have markers in CYP2C19 or ABCB1 indicative of reduced absorption or reduced activation of clopidogrel.

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