Now Has Six Liquid Biopsy CLIA Cancer Panels that Leverage Exceptional Sensitivity of Multiplexed ICE COLD-PCR™ to Detect Actionable Mutations in RAS and PIK3CA Genes Relevant to Treatment of Lung and Colorectal Cancers

OMAHA, Neb. (January 19, 2016) — Transgenomic, Inc. (NASDAQ: TBIO) today announced the launch of the MX-ICP RAS Analysis and the MX-ICP PIK3CA Analysis, two new cancer panels based on the company’s Multiplexed ICE-COLD PCR™ (MX-ICP) technology.

The MX-ICP RAS Analysis panel tests for relevant mutations in certain actionable genes, including KRAS and NRAS exons 2, 3 and 4. These genes are included in current colorectal cancer (CRC) treatment guidelines as important markers to detect reduced CRC tumor sensitivity to anti-EGFR antibody therapy, a current mainstay of treatment for colon cancer. An estimated 37–46% of patients with colorectal cancer have tumor-associated KRAS or NRAS mutations, which indicate that treatment with the EGFR blockers cetuximab or panitumumab will not be effective. MX-ICP provides amplified sensitivity for mutation detection down to 0.01%, making Transgenomic’s MX-ICP RAS Analysis more sensitive than RAS testing by traditional methods and helping enable precision treatment decisions.

The MX-ICP PIK3CA Analysis panel tests for mutations in the PIK3CA gene in colorectal cancer and non-small cell lung cancer (NSCLC) patients. Transgenomic has an exclusive license to test for the PIK3CA gene, which is available as a single gene test and is also included in the company’s MX-ICP NSCLC Analysis panel. 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 drug class as treatments for lung and colorectal cancer.

“The MX-ICP RAS Analysis and MX-ICP PIK3CA Analysis panels, which are now available for clinical diagnostic use through our CLIA laboratory, are the latest additions to our growing product line of tests for mutations in actionable genes designed to assist in personalizing and optimizing cancer treatment,” said Paul Kinnon, President and CEO of Transgenomic. “Our MX-ICP technology produces highly accurate results and requires 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 2016.”

Mr. Kinnon added, “We also have made specimen collection and shipping for our MX-ICP tests easier for customers. Our scientists have validated that samples containing just 10 ml of blood can now conveniently be shipped via overnight delivery at room temperature, in contrast to the larger samples and refrigeration requirements sometimes needed by other laboratories conducting mutation testing for cancer.”

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 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.


BLL Partners LLC
Barbara Lindheim

Transgenomic Investor Relations