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05/29/15 8:27 AM

#337 RE: iTrendz #336



OMAHA, Neb.--(BUSINESS WIRE)--May 29, 2015--

Transgenomic, Inc. (NASDAQ:TBIO) today announced the launch of its new Multiplexed ICE COLD-PCR(TM) (MX-ICP) CLIA service for mutation detection in cancer patients to enable more informed diagnoses, better treatment decisions and ongoing patient monitoring. The service leverages the ultra-high sensitivity of Transgenomic's proprietary MX-ICP technology to deliver highly accurate results from almost any type of patient sample. The first tests are for the detection of EGFR exon 20 T790M mutations that affect the utility of tyrosine kinase inhibitor (TKI) drugs used for non-small cell lung cancer and EGFR exon 12 S492R mutations that render colorectal cancer patients resistant to the widely-used drug cetuximab. Transgenomic intends to add additional single mutation and mutation panel detection tests to its suite of testing services in the coming months.

Bruce E. Johnson, MD, Chief Clinical Research Officer, Dana Farber Cancer Institute and Professor of Medicine, Harvard Medical School, noted, "The development of an accurate means to detect EGFR T790M with a blood test is an important development for our patients. We anticipate different drugs will be approved later this year for patients with acquired resistance to EGFR-TKIs and the presence of T790M in their tumor. Approximately 30% of our patients at the time of progression on EGFR-TKIs are unable to be biopsied, so an alternative means of testing using a blood-based test for assessing their status will be critical for this subset of EGFR-mutant NSCLC patients."

"Launching our Multiplexed ICE COLD-PCR-based CLIA mutation detection service for oncologists and their patients is a major milestone for Transgenomic and, we believe, an important advance for the field of precision medicine," said Paul Kinnon, President and Chief Executive Officer of Transgenomic. "The unsurpassed accuracy of MX-ICP and its ability to produce highly sensitive and accurate results from small amounts of almost any type of patient sample, especially liquid biopsies, allows broad use. This will enable far more patients to benefit from therapy optimized for their specific cancer and the insights into disease and treatment status obtained from ongoing monitoring during therapy, unlike currently-used tissue biopsies. Our first two tests focus on common treatment-relevant mutations in lung and colon cancer, and we intend to add new tests and test panels for other mutations and additional cancers in the coming months."