Transgenomic, Inc. Acquires Exclusive Worldwide License to Predictive Markers for Cancer Drug Response

OMAHA, Neb., May 26, 2011 /PRNewswire/ -- Transgenomic, Inc. (OTC/BB: TBIO) announced today that it has acquired an exclusive worldwide license to Montefiore Medical Center's (Bronx, NY, US) patent application, "Method of Determining the Sensitivity of Cancer Cells to EGFR Inhibitors including cetuximab, panitumumab and erlotinib".  The invention relates to the discovery by Montefiore scientists and collaborators that tumor-specific mutations in the genes PIK3CA and PTEN can aid in predicting patient non-response to epidermal growth factor receptor (EGFR) inhibitors, a widely prescribed class of cancer drugs.

Transgenomic is incorporating the PIK3CA and PTEN gene assays into its rapidly expanding menu of cancer profiling tests available through its clinical reference laboratories and is developing testing kits for sale to other labs. Testing of these genes is also being offered to support drug development research by pharmaceutical companies that have been expressing great interest in these genes and in Transgenomic's proprietary, ultra-sensitive mutation-detection technologies. At the American Association for Cancer Research meeting in April of this year, Transgenomic described methods for detecting tumor-specific mutations at such low levels that it may be possible to identify them in patients' blood samples, not just in surgically obtained tumor tissues.

"This exclusive license from Montefiore strengthens our cancer-related diagnostic test portfolio and is integral to the continued development of our leadership position in oncology," said Craig Tuttle, CEO of Transgenomic. "At Transgenomic, we are uniquely equipped to maximize the value of these genetic discoveries by combining them with the unparalleled sensitivity of our proprietary mutation-detection technologies. Our exclusive access to this new intellectual property will enable us to provide the most comprehensive analysis for predicting response to cancer treatment in the current market."

About PIK3CA and PTEN

Monoclonal antibody therapeutics that target the epidermal growth factor receptor (EGFR) are new and often highly effective treatments for metastatic colorectal cancer and other aggressive cancers. Unfortunately, some patients do not benefit from these drugs because their cancers have mutations in genes within the EGFR pathway.  The American Society of Clinical Oncology has recommended that colorectal cancer patients who are candidates for anti-EGFR therapy should be tested for mutations in the gene K-RAS as patients with mutations in K-RAS do not benefit from these therapies.  Studies from Montefiore Medical Center and elsewhere have demonstrated that mutations in PIK3CA and PTEN can also cause anti-EGFR therapies to be ineffective.  A diagnostic panel that comprehensively tests all these genes has the potential to greatly improve the tailored use of these cancer treatments.

About Transgenomic

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 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 application 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.

About Montefiore Medical Center

As the University Hospital for Albert Einstein College of Medicine, Montefiore is a premier academic medical center nationally renowned for its clinical excellence and scientific discovery; compassionate, patient-centered model of care; commitment to its community; and medical education, including the second largest residency program in the country. Montefiore is recognized among the top hospitals nationally and 6th out of 180 in the New York metro area by U.S. News & World Report. The Children's Hospital at Montefiore has consistently ranked in U.S. News "Americas Best Children's Hospitals," and is 2nd among those in the New York metro area. As an integrated health system, it is comprised of four hospitals, has 1491 beds and 93,000 annual hospital discharges, and is seamlessly linked by advanced technology. State-of-the-art primary and specialty care is provided through a network of nearly 100 locations across the region, including the largest school health program in the nation and a home health program. Inspired by its patients and its community, Montefiore is on the frontlines of developing innovative approaches to care and is a national model for excellence. www.montefiore.org and www.montekids.org 

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, Inc.

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