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Transgenomic, Inc. Expands SURVEYOR® Scan Product Line With BRAF and PIK3CA Mutation Detection Kits
Date:4/14/2011

OMAHA, Neb., April 14, 2011 /PRNewswire/ -- Transgenomic, Inc. (OTC/BB: TBIO) announced today that it has launched kits for high sensitivity mutational analysis of the BRAF and PIK3CA genes. These new kits complement the company's existing kits for detecting mutations in K-RAS, expanding Transgenomic's range of its proprietary SURVEYOR Scan mutation detection kit product line. Mutations in all three genes (K-RAS, BRAF, and PIK3CA) are widely accepted to be correlated with a lack of response to the class of lung and colorectal cancer drugs that are inhibitors of the epidermal growth factor receptor (EGFR).

"An increasing number of studies of the BRAF and PIK3CA genes have indicated that key mutations in these genes can confer resistance to EGFR inhibitors such as cetuximab (Erbitux®), gefitinib (IRESSA®), erlotinib (Tarceva®) and to the tyrosine kinase inhibitor imatinib (Gleevec®)," said Dr Katherine Richardson, VP of Research & Development at Transgenomic. "There is a need to have sensitive, reliable, quick and easy to use assays to test tumors for mutations in these genes. Unlike assays that are allele-specific, requiring labs to run a separate assay for every possible mutation, the SURVEYOR Scan kits will detect all mutations in the amplified gene targets at levels as low as 1% in a background of non-mutated DNA. The SURVEYOR Scan BRAF and PIK3CA kits empower robust, sensitive screening in research and diagnostic labs."

In the near future, Transgenomic expects to release CE IVD versions of the BRAF and PIK3CA kits for the European diagnostics market and plans to expand the SURVEYOR Scan product line with mutation detection kits for other key cancer pathway genes that can be used with WAVE HS, automated microfluidics platforms and even manually—a unique feature of Transgenomic's technology.

"Transgenomic has a strong track record in developing powerful mutation detection methods as our recent announcement on Ice COLD-PCR and BLOCker-Sequencing testifies," commented Craig Tuttle, Transgenomic's Chief Executive Officer. "We intend to transition our cutting edge research and development into commercial service laboratory assays as well as research-use-only and regulatory approved diagnostic kits. By combining our proprietary technologies and leveraging their unique properties for high sensitivity mutation detection, Transgenomic will advance its leading position in high sensitivity genetic analysis. Our newly developed SURVEYOR Scan BRAF and PIK3CA kits will further strengthen our portfolio."

About the SURVEYOR Nuclease and WAVE® HS DHPLC Platform

SURVEYOR Scan technology is a patented method for mutation detection that uses a PCR amplification reaction and hybridization to form mis-paired DNA molecules between normal and mutant sequences which are then cleaved using SURVEYOR Nuclease and detected on a chromatogram. Key features of the SURVEYOR Scan Kits include: (1) Detection of all known and unknown mutations in the amplicon of interest; (2) Inclusion of control templates for common mutation sites; (3) High analytic sensitivity, enabling the detection of a 1% mutant population in a background of wild-type genomic DNA, which would typically be missed by sequencing and other techniques; (4) Simple interpretation — the SURVEYOR fragment analysis pattern can aid in identifying the position of the mutation without the additional cost of full sequencing; (5) Convenient parallel processing facilitated by a single set of PCR conditions and analysis protocols for all kits; and (6) Successful application to DNA extracted from formalin-fixed paraffin-embedded tissues.

About Transgenomic, Inc.

Transgenomic, Inc. (www.transgenomic.com) 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 installed in customers' labs 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. Transgenomic Pharmacogenomics Services is a CRO for pharmacogenomic, translational research and clinical trials. The Transgenomic Molecular Laboratories specialize in molecular diagnostics for cardiology, neurology, mitochondrial disorders, oncology, hematology, molecular pathology and other inherited diseases. Transgenomic believes there is a significant opportunity to continue growing the demand for its molecular-based testing by leveraging core technologies, experience, and expertise in biomarker analysis. In addition, the company continues to seek out and evaluate new technologies and new tests to extend its offerings in molecular diagnostics and pharmacogenomics services.

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.

© 2011 Transgenomic, Inc. "TRANSGENOMIC", "WAVE" and "SURVEYOR" are registered trademarks of Transgenomic, Inc.


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