Transgenomic Expands Distribution of SURVEYOR® Scan K-RAS Mutation Detection Kit With CE IVD Mark

OMAHA, Neb., Sept. 13 /PRNewswire/ -- Transgenomic, Inc. (OTC Bulletin Board: TBIO) today announced that it completed the requirements for CE IVD labeling and has significantly expanded distribution of its SURVEYOR® Scan K-RAS mutation detection kit throughout most of the European Union. The SURVEYOR Scan K-RAS CE IVD kit is a member of Transgenomic's family of mutation detection kits, which features proprietary SURVEYOR endonuclease technology.  The SURVEYOR Scan is a novel approach to mutation detection, which has been shown to provide comparable sensitivity and greater specificity than other commercially available kits.  CE IVD designation is required for commercial sales. The CE IVD labeled kit will be available in the United Kingdom, Ireland, Austria, Belgium, Czech Republic, Denmark, France, Germany, Italy, The Netherlands, Poland, Slovakia, Slovenia, Spain, Sweden and Switzerland.  The Company will also continue to offer worldwide a research use only version of the kit.

"The key advantage of SURVEYOR Scan is that it is able to detect all mutations present in the entire amplified gene fragment versus looking only at a subset of the most common mutations," said Transgenomic's technical director, Dr. Katherine Richardson.  "Being able to identify all mutations, including point mutations, insertions and deletions, in the amplified region increases the clinical sensitivity of the kit, as it will find genetic changes other kits will miss.  In addition, the detection of all mutations will result in a mutation 'signature' for the amplified gene region.  Compiling these mutation signatures may become necessary when using drug cocktails for individualized therapy, since the complete knowledge of the mutation profile for specific tumors and/or genes may be necessary to determine the specific make-up of the drug cocktail."

Craig Tuttle, Transgenomic's Chief Executive Officer, said, "Achievement of the CE IVD label greatly expands the market for the K-RAS kits, and given our very strong presence in molecular diagnostics laboratories in Europe, we are optimistic about their reception in the commercial setting.  The combination of SURVEYOR with the WAVE® HS platform delivers a highly sensitive, easy to use and cost effective way to measure somatic mutations not only in K-RAS genes, but will soon include BRAF, PIK3CA, EGFR, p53 and a host of other genes involved in cancer.  The ability to offer a family of CE IVD-labeled mutation detection kits for diagnostic use on our WAVE HS as well as other platforms commonly used in molecular diagnostic laboratories is a significant competitive advantage.  In short, our K-RAS CE IVD kit is expected to be the first in a line of kits and automated system options offered by Transgenomic.

"As demand for tests with greater sensitivity and specificity grows, we have also responded by designing a K-RAS kit in combination with our new proprietary technology COLD-PCR, which will permit the detection of mutations in circulating blood with as much as 100 times the sensitivity of currently available tests and will be run with SURVEYOR not only on our WAVE, but with other systems. We look forward to launching this kit in the next few months.  We have shown 100 percent concordance between our mutation results obtained in plasma and the matched tumor K-RAS genotype, and continue our work with other mutations including B-RAF and p53. Eventually we will combine COLD-PCR with a number of kits for detecting the major mutations implicated in cancer and other diseases," Mr. Tuttle added.

About the SURVEYOR® Scan K-RAS Mutation Detection kit CE IVD for WAVE® HS Systems

After performing a PCR reaction, the company's SURVEYOR nuclease is used to cleave the DNA strand at the site of the mutation which generates DNA fragments.  The different sized fragments of DNA present as individual peaks on a chromatogram when compared to wild type DNA.  

Numerous scientific studies report that K-RAS mutation status is a strong predictor of resistance to cancer treatment with epidermal growth factor receptor inhibitors. Determining the K-RAS mutation status  is especially important when determining treatment regimens for patients with colorectal cancer. Transgenomic's SURVEYOR Scan K-RAS Mutation Detection Kit CE IVD uses the established SURVEYOR Nuclease technology to identify mutations in the K-RAS gene that are associated with drug-resistant tumors.   Key features include:

• Detects mutations by enzymatic cleavage at mutation sites due to mutant:wild-type heteroduplex formation
• Identifies all known and unknown mutations in both K-RAS coding exons
• Includes control templates for common mutation sites (codons 12, 13 and 61)
• High analytic sensitivity — detects 1% of K-RAS mutant in a background of wild-type genomic DNA
• Finds low level mutations frequently missed by sequencing
• Simple interpretation — the SURVEYOR fragment analysis pattern can identify the position of mutation
• Can be applied to paraffin-embedded tissues

SURVEYOR Scan K-RAS is the first of a series of kits for use in cancer mutation detection.  Transgenomic plans to follow it with kits for BRAF, PI-3 kinase, p53 and other key cancer genes in the near future.

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. 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, nearly 1,500 systems have been shipped to customers in more than 50 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 with 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 Pharmacogenomics Services is a CRO for pharmacogenomic, translational research and clinical trials.

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.