Transgenomic expands EU distribution of SURVEYOR Scan K-RAS CE IVD mutation detection kit

Transgenomic, Inc.Sep 14 2010

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.