Transgenomic, Inc. Launches First Commercially Available Assay For Ultra Low Level Detection Of EGFR C797S Mutations That Predict Resistance To Third Generation Kinase Therapies For Lung Cancer

OMAHA, Neb.--(BUSINESS WIRE)--Transgenomic, Inc. (NASDAQ: TBIO) today announced the launch of its EGFR C797S Mutation Detection Assay based on the company’s ICE COLD-PCR^™ (ICP) technology. This new test detects the presence of the EGFR C797S mutation that is associated with resistance to new third-generation tyrosine kinase inhibitor (TKI) therapies in development for non-small cell lung cancer (NSCLC), one of the most common and deadly cancers in the US. The ultra-high sensitivity of Transgenomic’s ICP technology makes it possible to run the new assay using either tissue, blood or serum samples. The test is currently available for research use through Transgenomic’s Biomarker Discovery Services group and is expected to be available for clinical use through the company’s Oncology CLIA laboratory in Omaha, Nebraska later this year.

“Our rapid introduction of this important assay is an excellent example of our team’s ability to quickly produce ICE COLD-PCR based tests in response to the need for biomarkers relevant to the many new targeted cancer therapies being developed by pharmaceutical and biotechnology companies.”

Transgenomic President and CEO Paul Kinnon commented, “Our rapid introduction of this important assay is an excellent example of our team’s ability to quickly produce ICE COLD-PCR based tests in response to the need for biomarkers relevant to the many new targeted cancer therapies being developed by pharmaceutical and biotechnology companies.”

Mr. Kinnon continued, “The EGFR C797S mutation is an important predictor of resistance in third-generation TKI therapies for NSCLC and requires a very high sensitivity assay for early detection of possible resistance using the blood or serum samples that are the only option available during ongoing treatment. Our ICP technology is an ideal solution--it has very high sensitivity and can be analyzed using any of the latest sequencing platforms. In addition, ICP also detects unknown (non-allele specific) mutations so that new prognostic markers can be identified in the course of testing.”

While the new assay detects EGFR mutation C797S, Transgenomic also has an assay for the EGFR T790M mutation, a known marker for resistance in first generation TKI therapies. This assay enriches for mutations in codon 790 and its immediately adjacent codons, while the new assay enriches for mutations in codon 797 and its immediately adjacent codons.

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. ICP 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 about Transgenomic’s EGFR assays and its Biomarker Discovery Services, 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.