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Transgenomic, Inc. Executes License Option agreement for Parkinson's Disease Diagnostic Markers with Gene Solutions, LLC

OMAHA, Neb., Dec. 17 /PRNewswire-FirstCall/ -- Transgenomic, Inc. (OTC Bulletin Board: TBIO) announced today that it has reached agreement with Gene Solutions for an exclusive licensing option to a set of validated mutations found in Parkinson's disease patients that can form the basis of a novel and accurate diagnostic test for Parkinson's disease. Transgenomic's platform mitochondrial mutation detection technology will be evaluated and optimized to develop a diagnostic test that evaluates and quantitates the presence of low-level mitochondrial DNA (mtDNA) variants. These mutations have been demonstrated to be present in Parkinson's disease patients but rarely in age-matched control individuals.

Parkinson's disease is a devastating neurological disorder affecting at least 1 million diagnosed patients and potentially another 3-4 million undiagnosed patients in the US alone. Symptoms can be modified to some degree by early intervention and treatment with dopamine or other neurological enhancing agents. The earlier the diagnosis, the better the long-term outcome can be for the sufferers of this disease. But often the disease has progressed significantly before a diagnosis can be accurately made and treatment initiated.

Each cell in the body has hundreds to thousands of mitochondria, organelles that produce the energy required for cells to function normally. Mitochondria contain their own genome that encodes many of the proteins necessary to perform cellular energy production. Damaged or mutated mitochondrial DNA (mtDNA) leads to cellular metabolism disorders by interfering with energy production. A large body of research conducted over the past twenty years has implicated mitochondrial abnormalities in certain neurodegenerative diseases including Parkinson's disease. Gene Solutions has discovered a specific region of mtDNA in which variants in the genetic sequence are present in Parkinson's patients. These variants are present at a very low level, in the range of 1% of mtDNA molecules, making identification of them very difficult with usual mutation detection methods.

"Transgenomic has historically been focused on high-sensitivity mutation detection and more recently we have developed a strong mitochondrial DNA mutation service in our CLIA-certified laboratory," said Craig Tuttle, Chief Executive Officer. "As a result, there is an extremely natural fit with Gene Solutions' Parkinson's disease mutations discovery and an exciting commercial opportunity to transform this observation into a powerful and necessary diagnostic product. In addition, we see potential application for COLD-PCR, a technology licensed exclusively from the Dana Farber Cancer Institute for applications to mitochondrial DNA mutation enrichment and detection."

Dr. W. Davis Parker, discoverer of the variants and founder of Gene Solutions, said "We are delighted to form a partnership with Transgenomic to evaluate their broad technology platform's ability to detect the Parkinson's disease mutations and to develop a diagnostic product that could enrich the lives of many patients through earlier diagnosis and treatment of this devastating disease."

About Gene Solutions

Gene Solutions, LLC is an early-stage discovery and development company based in Charlottesville, VA, focused on genetic causes and potential cures for selected neurological diseases. The company's key intellectual property and discovery platform is based on more than 25 years of validated research conducted by the founder, Dr. William Davis Parker.

About Transgenomic

Transgenomic, Inc. (OTC BB: TBIO.OB, is a global biotechnology company specializing in high sensitivity genetic variation and mutation analysis, providing products and services in DNA mutation detection and discovery for clinical research, clinical molecular diagnostics and pharmacogenomics analyses. Its product offerings include the WAVE® Systems and associated consumables specifically designed for use in genetic variation detection and single- and double-strand DNA/RNA analysis and purification. With broad applicability to genetic research, over 1,450 systems have been shipped to customers in more than 30 countries. The SURVEYOR® Mutation Detection Kits and SURVEYOR Check-It Kit provide reagents and protocols for high sensitivity detection of mutations in DNA. In addition, HANABI automated chromosome harvesting systems improve laboratory productivity with consistent quality compared to manual methods for cytogenetic analyses. Service offerings include the Transgenomic Molecular Laboratory, which provides reference laboratory services specializing in molecular diagnostics including Mitochondrial Disorders, Oncology and Hematology, Molecular Pathology and Inherited Diseases. Transgenomic Pharmacogenomic Services is a CRO for pharmacogenomic, translational research and clinical trials.

Cautionary Statements

Certain statements in this press release constitute "forward-looking statements" 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 reports to 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.

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SOURCE Transgenomic, Inc.

SOURCE Transgenomic, Inc.
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