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Transgenomic Expands COLD-PCR License

OMAHA, Neb., March 14, 2011 /PRNewswire/ -- Transgenomic, Inc. (OTC Bulletin Board: TBIO) today announced the completion of an expanded license with the Dana-Farber Cancer Institute, Boston, MA, for the COLD-PCR (CO-amplification at Lower Denaturing temperature PCR) technology. Previously, Transgenomic had licensed exclusive rights to COLD-PCR for Sanger Sequencing and mitochondrial DNA analysis. The new license expands the technology covered to include Ice COLD-PCR, a technique that further extends the sensitivity of mutation detection provided by this key technology and also extends the Company's licensed exclusivity to include analysis of COLD-PCR products by Pyrosequencing.

COLD-PCR is a genetic testing approach that selectively amplifies mutant DNA by recognizing that mutant DNA strands denature at lower temperatures in a PCR reaction than normal DNA. Using this proprietary technique, COLD-PCR amplifies mutated DNA with minimal amplification of the normal DNA. The resultant PCR-amplified fragment can be easily analyzed with a variety of sequencing approaches including Sanger sequencing, Pyrosequencing, real-time PCR or any next generation sequencing technology. Transgenomic has licensed rights to utilize any of these techniques. The enhanced analytic sensitivity of COLD-PCR allows clinicians to use smaller amounts of sample for their genetic analysis and less intrusive sample collection methods such as a blood draw for serum or plasma preparation, urine, fine needle aspirates or bronchial lavage as well as studying mutated DNA in tumors directly. The addition of the Ice COLD-PCR methodology further enhances the sensitivity.

Craig Tuttle, Transgenomic CEO, noted: "One of our long-term corporate strategic initiatives has been to continually develop ultra-high sensitivity assays and technologies for the detection of low level DNA mutations. Ice COLD-PCR enables us to continue this effort. We have developed a variety of gene mutation assays now using COLD- and now Ice COLD-PCR and have obtained mutation detection levels that allow post-enrichment Sanger sequencing of somatic mutations which had initial concentrations in the sample of lower than 0.05% that of the wild type allele. This is in comparison to a typical detection level of 10% using Sanger sequencing alone. We are applying our enhanced technology to studying mutant DNA levels in plasma/serum and CTCs that correspond to the mutation found in tumors - thus demonstrating that this technique could serve as a screening or earlier detection method for finding these mutations in blood."

"Ice COLD-PCR is an important addition to our range of technologies as it is a key element in the development of improved levels of detection of mutations. By expanding our license to include additional sequencing methods, we are broadening the market opportunity for COLD-PCR under our exclusive license with the Dana-Farber Cancer Institute."

About Transgenomic, Inc.

Transgenomic, Inc. ( 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. 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, nearly 1,500 systems have been shipped to customers in more than 50 countries. The SURVEYOR® Mutation Detection Kits provide reagents and protocols for high sensitivity detection of mutations in DNA.  HANABI automated chromosome harvesting systems improve laboratory productivity with consistent quality compared with manual methods for cytogenetic karyotyping and FISH 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 Pharmacogenomics Services is a CRO for pharmacogenomic, translational research and clinical trials.  In December of 2010, we acquired another CLIA certified laboratory in New Haven, Connecticut which specializes in genetic disorders associated with cardiomyopathies and channelopathies.  We believe there is a significant opportunity for us to continue growing the demand for molecular-based testing by leveraging our technologies, experience and expertise in biomarker analysis. In addition, we continue to seek out and evaluate new technologies and new laboratory tests which will further extend our offerings in our Molecular Diagnostics Laboratory and our Pharmacogenomics Services Lab.

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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