Transgenomic Launches EGFR CLIA Test That Accurately Detects Key Mutations in Solid and Liquid Patient Samples Using Multiplexed ICE COLD-PCR

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Transgenomic, Inc.
TBIO
today announced the launch of its new Multiplexed ICE COLD-PCR™ (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." Multiplexed ICE COLD-PCR achieves its ultra-high sensitivity by preferentially enriching the scarce mutant DNA sequences present in an ocean of wild-type (normal) DNA through selective amplification of the mutant DNA. The result is up to a 500-fold increase in sensitivity in identifying mutations with the most precise sequence alteration detection rates available--down to 0.01% from as little as 4-5 ml of plasma sample, making it possible to obtain accurate and sensitive biopsies using either liquid or solid tissue specimens. ICE COLD-PCR was originally developed by the laboratory of Dr. Mike Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively licensed rights to the technology to Transgenomic. The new service will accept a wide range of patient samples, including tissue, plasma, fine needle aspiration, bronchoscopy, cytology and other body fluid samples. Actionable results will be available in 7-10 working days. Additional tests and panels for mutations in EGFR, KRAS, NRAS, PIK3CA, BRAF and other genes are currently in development. Transgenomic also announced the publication and availability of a study abstract at the 2015 ASCO Annual Meeting website and at our booth confirming the clinical utility of expanded screening of KRAS and NRAS genes in colorectal cancer patients using Transgenomic's CRC RAScan™ test.1 KRAS and NRAS mutations are found in approximately one-quarter of human tumors. They lead to activation of RAS family genes that play a critical role in determining response to EGFR mutation-targeted therapies such as cetuximab and panitumumab. Presence of KRAS exon 2 mutation status has been used as a key predictor of response to anti-EGFR therapy. However, about 10% of patient tumors that do not have a mutation in KRAS exon 2 have been found to have mutations in KRAS exons 3 or 4 or in NRAS exons 2, 3, or 4, which also respond poorly to anti-EGFR treatment. Evaluation of colorectal cancer cases tested in Transgenomic's laboratory facility identified almost one-quarter with these mutations. Of these, 45% had the expected mutation in KRAS exon 2, but the other 55% had mutations in KRAS exon 3 or 4, or in NRAS exon 2 and 3. These findings suggest that screening for mutations in these other gene regions could play an important role in improved management of colorectal cancer. The authors conclude that the study results confirm that using the CRC RAScan test as a screen ensured the more effective use of anti-EGFR therapies for individuals with metastatic colorectal cancer. For more information on Transgenomic's CLIA services for KRAS and NRAS testing, click here. For more information on its EGFR CLIA tests, click here. 1 Clinical utility of expanded screening of the KRAS and NRAS genes for Metastatic Colorectal Cancer: Evaluation of the CRC RAScan tumor test as a companion diagnostic to determine efficacy of anti-EGFR therapies. KA Richardson, S Peterson, J Bevilacqua, S Veys, V Rosendale, BL Legendre, KC Bible, H Reddi; Abstract No: e12554J; Clin Oncol 33, 2015 (suppl; abstr e12554)
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