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Transgenomic Develops New Assays to Detect EGFR Mutations Using COLD-PCR
Date:11/8/2010

OMAHA, Neb., Nov. 8, 2010 /PRNewswire-FirstCall/ -- Transgenomic, Inc. (OTC Bulletin Board: TBIO) today announced completion of a development study of several new assays to detect genetic mutations using the Company's proprietary Co-amplification at Lower Denaturing Temperature PCR (COLD-PCR) technology in the Epidermal Growth Factor Receptor (EGFR) gene. EGFR mutations are found in a number of cancers, including lung and colorectal cancers.  Several new targeted cancer therapeutics called tyrosine kinase inhibitors (TKIs) have been approved or are in clinical trials to be used as front line or secondary therapies against these cancers. The presence of mutations in certain regions of the EGFR gene are key criteria to determine whether or not a patient should receive TKI inhibitor therapy.

In its study, Transgenomic looked at the ability of COLD-PCR to detect EGFR mutations in exons 19-21.  Study results indicate that the COLD-PCR assays detect all exon 19 deletions, the T790M mutation in exon 20 and all mutations in exon 21 in the specific regions amplified, including L858R and L861Q point mutations.  The sensitivity of detection when confirmed using Sanger sequencing is 0.05% to 0.2% using plasmid and cell line DNA dilutions.  Preliminary experiments on DNA isolated from plasma samples are currently underway, and early results are mimicking the plasmid and cell line DNA studies.  Transgenomic's assays were developed in collaboration with the Dana-Farber Cancer Institute and a major oncology pharmaceutical partner.

Craig Tuttle, Transgenomic CEO, commented, "One of our key corporate strategic initiatives is to develop ultra-high sensitivity assays for the detection of low-level DNA mutations in body fluids.  We believe COLD-PCR provides us with the analytical sensitivity and accuracy to achieve this goal.  We have always belie
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SOURCE Transgenomic, Inc.
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