News | March 08, 2012

Transgenomic’s Clopidogrel Response Panel Validates Use of Genetic Marker Testing

March 8, 2012 — Transgenomic Inc. announced the publication of a new study by researchers at Vanderbilt University that further validates the role of both genes found in the company’s PGxPredict: Clopidogrel (Plavix) Panel, a comprehensive test to predict a patient’s response to clopidogrel (Plavix).

The study confirms the results of two previous studies demonstrating that outcomes in patients receiving clopidogrel were better for patients without genetic variations in CYP2C19, a gene whose effect is described in the drug’s label, and ABCB1, a gene that is unique to the panel and is covered by issued and pending patents owned by Transgenomic. The results were published by Delaney, et al., in the February issue of Clinical Pharmacology and Therapeutics,

The effectiveness of clopidogrel, the most widely prescribed antiplatelet drug used to reduce the risks of death, stroke and heart attack in heart disease patients, is dependent on CYP2C19, a gene that codes for an enzyme responsible for metabolizing clopidogrel into its active form. As a result, patients with a dysfunctional variation in CYP2C19 who are treated with clopidogrel exhibit higher cardiovascular event rates than do patients with normal CYP2C19 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 risk.

Researchers in the United States and France recently demonstrated that, in addition to CYP2C19, genetic variation in ABCB1 is also predictive of therapeutic outcomes for patients taking clopidogrel, due to the gene product’s role in transporting clopidogrel into the bloodstream. The Vanderbilt study is now the third independent study demonstrating the value of testing both CYP2C19 and ABCB1 to identify patients at increased risk for death, stroke and heart attack due to ineffective antiplatelet therapy.

“A growing number of large, independent studies support the clinical importance of testing for genetic variants in both CYP2C19 and ABCB1 to predict clopidogrel response and establish the appropriate treatment strategy for each patient,” said Craig Tuttle, CEO of Transgenomic. “There are approximately 6 million new patients prescribed Plavix each year. Approximately 47 percent will not get the full benefit of the therapy due to genetic variations in either CYP2C19 or ABCB1. The PGxPredict: Clopidogrel Panel is the only panel to test for genetic variations in both CYP2C19 and ABCB1 and represents a potential multibillion-dollar market opportunity for our Clinical Laboratories division.”

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