Transgenomic’s Proprietary Clopidogrel (Plavix®) Response Panel Includes Both Genetic Markers Demonstrated to Be Significant in Third Independent Study Results Published in Clinical Pharmacology and Therapeutics OMAHA, Neb. (March 1, 2012) – Transgenomic, Inc. (OTC/BB: TBIO) today 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 Transgenomic’s 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 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% 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 multi-billion dollar market opportunity for our Clinical Laboratories division.” This publication can be accessed via the following link:
About the PGxPredict:CLOPIDOGREL Panel
The PGxPredict:CLOPIDOGREL Panel analyzes the genes CYP2C19 and ABCB1 to help predict a patient’s response to clopidogrel (Plavix®), a widely used antiplatelet drug. The test results can be used to aid clinicians in developing a treatment plan for their patients being considered for or receiving clopidogrel. About Transgenomic, Inc. Transgenomic, Inc. () is a global biotechnology company advancing personalized medicine in cancer and inherited diseases through its proprietary molecular technologies and world-class clinical and research services. The company has three complementary business divisions: Transgenomic Pharmacogenomic Services is a contract research laboratory that specializes in supporting all phases of pre-clinical and clinical trials for oncology drugs in development. Transgenomic Clinical Laboratories specializes in molecular diagnostics for cardiology, neurology, mitochondrial disorders, and oncology. Transgenomic Diagnostic Tools produces equipment, reagents, and other consumables that empower clinical and research applications in molecular testing and cytogenetics. Transgenomic believes there is significant opportunity for continued growth across all three businesses by leveraging their synergistic capabilities, technologies, and expertise. The company actively develops and acquires new technology and other intellectual property that strengthen its leadership in personalized medicine. Forward-Looking Statements for Transgenomic Certain statements in this press release constitute “forward-looking statements” of Transgenomic within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not limited to, those with respect to management's current views and estimates of future economic circumstances, industry conditions, company performance and financial results, including the ability of the Company to grow its involvement in the diagnostic products and services markets. The known risks, uncertainties and other factors affecting these forward-looking statements are described from time to time in Transgenomic's filings with the Securities and Exchange Commission. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. Accordingly, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 with respect to all statements contained in this press release. All information in this press release is as of the date of the release and Transgenomic does not undertake any duty to update this information, including any forward-looking statements, unless required by law.
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