Healthcare Industry News:  Cytogen 

Diagnostics Cardiology Reimbursement

 News Release - July 24, 2012

Transgenomic Announces Medicare Coverage for Clopidogrel (Plavix(R)) Response Test

OMAHA, Neb.--(Healthcare Sales & Marketing Network)--Transgenomic, Inc. (TBIO) today 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% increase in major adverse cardiovascular event rates than do patients with normal CYP2C19 and ABCB1 genetic 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 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% of patients taking clopidogrel have markers in CYP2C19 or ABCB1 indicative of reduced absorption or reduced activation of clopidogrel.

“Confirmation of Medicare coverage is a major commercial milestone for Transgenomic and an important step toward widespread use of C-GAAP,” said Craig Tuttle, Chief Executive Officer of Transgenomic. “Medicare is the largest U.S. payor and currently covers approximately 75% of the patients for whom the C-GAAP test would be ordered. Acceptance by Medicare removes a significant barrier for physicians and allows for a more rapid adoption of this important genetic test. There are approximately 6 million new patients that are prescribed clopidogrel each year. Half of those patients have genetic variations in CYP2C19 or ABCB1 which will limit the effectiveness of clopidogrel therapy. C-GAAP provides their physicians the additional clinical information that can help them choose the most effective treatment alternative to reduce their patient’s risk of a major adverse cardiac event. It will also help patients feel comfortable with their physician’s therapy selection.”

About Transgenomic, Inc.

Transgenomic, Inc. (www.transgenomic.com) 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 which specializes in molecular diagnostics for cardiology, neurology, mitochondrial disorders, and oncology; and Transgenomic Diagnostic Tools which 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 strengthens its leadership in personalized medicine.

Forward-Looking Statements

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.


Source: Transgenomic

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