New Release in Line of Liquid Biopsy CLIA Tests that Leverage Exceptional Sensitivity of Multiplexed ICE COLD-PCR™; Conforms to ASCO and NCCN Testing Recommendations
OMAHA, Neb. (November 5, 2015) –– Transgenomic, Inc. (NASDAQ: TBIO) today announced the launch of its new comprehensive Multiplexed ICE-COLD PCR™ (MX-ICP) Non-Small Cell Lung Cancer (NSCLC) Analysis panel that covers the key actionable mutations that are relevant to the targeted treatment of NSCLC, one of the most common types of cancer and the leading cause of cancer deaths in the US. The panel uses Transgenomic’s MX-ICP technology that generates highly accurate results from small amounts of blood or tissue samples at precision detection levels down to as low as 0.01%. It is available for clinical diagnostic use through the company’s CLIA laboratory.
The MX-ICP NSCLC Analysis panel tests for the relevant mutations in important actionable genes, including EGFR exons 18-21, KRAS exons 2 and 3, BRAF 15 (V600E) and PIK3CA exons 9 and 20. These genes are either included in current lung cancer treatment guidelines or are thought to affect the potential utility of oncology drugs in clinical trials for the treatment of NSCLC.
Testing for EGFR exons 18-21 is endorsed by the guidelines of the National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology (ASCO) for determining initial NSCLC treatment options and for monitoring for mutations that may affect the therapeutic utility of EGFR-tyrosine kinase inhibitor (TKI) drugs used to treat lung cancer. In addition, Transgenomic has an exclusive license to test for the PIK3CA gene, which is included in the NSCLC Analysis panel and is also available as a single gene test. This gene is of interest since there are a number of clinical trials underway to determine the effectiveness of PIK3 inhibitors and the related mTOR inhibitor class as treatments for lung cancer.
“The launch of this expanded NSCLC Analysis panel reflects our goal of making our MX-ICP-based CLIA tests widely available to cancer patients and their physicians,” said Paul Kinnon, President and CEO of Transgenomic. “The new panel broadens the utility of our initial EGFR tests by including most of the actionable mutations that are currently known to affect the utility of targeted therapies for lung cancer and continues our commitment to launch six CLIA tests in the second half of 2015. Our MX-ICP technology produces highly accurate results that require only small amounts of blood or plasma, making it suitable for ongoing patient monitoring over the course of treatment. We expect to add additional tests and panels to our suite of CLIA mutation detection tests in the coming months.”
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 — down to 0.01% from as little as a 4 ml plasma sample. 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 CLIA lung cancer tests, click here.
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 and sells equipment, reagents and other consumables for applications in molecular testing and cytogenetics. Transgenomic’s diagnostic technologies are designed to improve medical diagnoses and patient outcomes.
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.
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