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news out - Transgenomic Launches New MX-ICP Liquid Biopsy Tests for Comprehensive Detection of Colorectal and Melanoma Tumor Mutations

Date : 03/10/2016 @ 7:30AM
Source : Business Wire



Transgenomic Now Has Eight Liquid Biopsy CLIA Cancer Panels that Leverage the Ultra-High Sensitivity of Multiplexed ICE COLD-PCR™ to Detect Actionable Mutations in Genes Relevant to Treatment of Lung Cancer, Colorectal Cancer and Melanoma

Transgenomic, Inc. (NASDAQ:TBIO) today announced the launch of its MX-ICP CRC Analysis and MX-ICP Melanoma Analysis, two new liquid biopsy cancer panels based on the company’s Multiplexed ICE COLD-PCR™ (MX-ICP) technology. These new tests are among the first to provide comprehensive coverage of all relevant genes for colorectal cancer (CRC) and melanoma and are intended to enable precision treatment decisions. They are available for clinical use through Transgenomic’s Oncology CLIA laboratory in Omaha, Nebraska.

MX-ICP CRC Analysis is a comprehensive panel that tests for the relevant mutations in a range of actionable genes and includes KRAS and NRAS exons 2, 3 and 4; BRAF exon 15; PIK3CA exons 9 and 20; and EGFR exon 12 (S492R). These are among the most common gene mutations that have been identified in colorectal cancer patients--they are found in more than half of CRC tumors. Mutations in these genes have been associated with response to current or investigational therapies and can therefore provide guidance on treatment decisions.

The MX-ICP Melanoma Analysis panel tests for BRAF exon 15 and NRAS exon 2 and 3 mutations, which have been identified in approximately 50-75% of malignant melanoma tumors and are associated with differential response to treatment.

MX-ICP provides amplified sensitivity for mutation detection down to 0.01%, making the MX-ICP CRC and Melanoma Analyses more sensitive than testing by traditional methods and providing oncologists with potentially more accurate information for treatment decisions.

Transgenomic President and CEO Paul Kinnon commented, “Despite recent gains in treatment, CRC is the second leading cause of cancer-related deaths in the US, with an annual toll of more than 49,000. Metastatic melanoma remains a deadly disease, with 5-year survival rates of only 10%. The high level of unmet medical need in these conditions is spurring development of many new treatment options that make the use of genomic-based analysis for personalized medicine all the more essential. We believe that our new CRC and Melanoma Analysis panels are among the most accurate and comprehensive available, and we are very pleased that they are now available to patients and physicians through our Omaha CLIA laboratory, as part of our growing portfolio of genomic cancer tests.”

Multiplexed ICE COLD-PCR achieves its ultra-high sensitivity through selective amplification of 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. 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.

For more information on Transgenomic’s portfolio of CLIA cancer tests, click here.

About Transgenomic
Transgenomic, Inc. is a global biotechnology company advancing personalized medicine in cardiology, oncology, and inherited diseases through advanced diagnostic technologies, such as its revolutionary ICE COLD-PCR™ and its unique genetic tests provided through its Patient Testing business. Transgenomic also provides specialized clinical and research services to biopharmaceutical companies developing targeted therapies. Transgenomic’s diagnostic technologies are designed to improve medical diagnoses and patient outcomes.

Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” of Transgenomic within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. The known risks, uncertainties and other factors affecting these forward-looking statements are described from time to time in Transgenomic's filings with the Securities and Exchange Commission, including in Transgenomic’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on April 15, 2015. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. Accordingly, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 with respect to all statements contained in this press release. All information in this press release is as of the date of the release and Transgenomic does not undertake any duty to update this information, including any forward-looking statements, unless required by law.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160310005203/en/

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Barbara Lindheim, 212-584-2276
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