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Transgenomic Demonstrates Very High Sensitivity Detection of Tumor-Associated KRAS Mutations in Matched Plasma Samples Using COLD-PCR
Date:2/8/2010

OMAHA, Neb., Feb. 8 /PRNewswire-FirstCall/ -- Transgenomic, Inc. (OTC Bulletin Board: TBIO) announced today that it has completed a preliminary study with a leading pharmaceutical company that validates the use of its licensed COLD-PCR technology to detect colorectal tumor-associated KRAS mutations that determine efficacy of recently developed therapies. These were detected in plasma samples in which the mutation levels were too low for detection by standard DNA analysis methodologies such as Sanger sequencing.

The study, which was performed by Transgenomic's Pharmacogenomics Services Laboratory in Omaha, NE and the company's Molecular Biology research team in Gaithersburg, MD, consisted of testing DNA extracted from colorectal tumor-matched plasma samples. Screening with standard Sanger sequencing of the plasma samples resulted in only 70% concordance between matched plasma and tumor due to missing KRAS codon 12 and 13 mutations.

The samples were enriched by Transgenomic's COLD-PCR mutation enrichment technology before analysis with the SURVEYOR SCAN KRAS assay. COLD-PCR preferentially amplifies genomic DNA mutations in comparison to normal, wild-type sequences. This powerful enrichment and screening method can detect matched-tumor KRAS mutations in serum mutation levels at less than 0.1% of total wild-type DNA.

This resulted in the accurate detection of all KRAS codon 12 and KRAS codon 13 mutations with full discrimination against wild-type or normal samples tested concurrently. Due to the extent of the enrichment process, all of these KRAS containing plasma samples could subsequently be verified by DNA sequencing.

It was confirmed by the study's pharmaceutical partner that there was a 100% concordance between Transgenomic's mutation results and the matched tumor KR
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SOURCE Transgenomic, Inc.
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