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Transgenomic Expands Distribution of SURVEYOR® Scan K-RAS Mutation Detection Kit With CE IVD Mark
Date:9/13/2010

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 muta
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SOURCE Transgenomic, Inc.
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