NEW YORK (GenomeWeb News) – Transgenomic today announced it has received confirmation of Medicare coverage for its clopidogrel response test.
National Government Services, the Medicare fiscal intermediary for Connecticut, has confirmed coverage for Transgenomic's Clopidogrel Genetic Absorption Activation Panel, or C-GAAP, providing 48 million Americans currently on Medicare access to the test, formerly called PGxPredict: Clopidogrel.
The saliva-based test identifies patients with mutations to their CYP2C19 and ABCB1 genes that cause them to incompletely absorb or activate clopidogrel, which also goes under the brand name Plavix. C-GAAP analyzes markers in both genes to identify those patients who are at genetically heightened risk for major adverse cardiovascular events because of diminished effectiveness of the drug.
According to Transgenomic about half of all patients on clopidogrel have markers in CYP2C19 or ABCB1 indicative of compromised absorption or activation of the drug. In 2010, the US Food and Drug Administration issued a "black box" warning to Plavix's label to highlight that patients with the CYP2C19*2/*2 genotype and treated with the drug exhibit higher rates of adverse cardiovascular events than patients with normal CYP2C19 function.
Craig Tuttle, CEO of Omaha, Neb.-based Transgenomic, called the Medicare decision a "major commercial milestone" for the firm "and an important step toward widespread use of C-GAAP. Medicare covers about 75 percent of patients for whom the test would be ordered and acceptance by the insurance program "removes a significant barrier for physicians and allows for a more rapid adoption of this important genetic test," he said.