Transgenomic, Inc. Launches First Commercially Available CLIA Test For Detection Of EGFR C797S Mutations That Predict Resistance To 3rd Generation Kinase Therapies For Lung Cancer

OMAHA, Neb.--(BUSINESS WIRE)--Transgenomic, Inc. (TBIO), (NASDAQ: TBIO) today announced the launch of its new CLIA assays that detect the presence of the EGFR C797S mutation, a novel mechanism of acquired resistance to third-generation tyrosine kinase inhibitor (TKI) drugs for non-small cell lung cancer (NSCLC). The C797S detection test is available as a solo assay and in three panels--TBIO’s EGFR-TKI resistance panel that also tests for the EGFR T790M mutation, its MX-ICP EGFR NSCLC panel and its MX-ICP EGFR Analysis panel, which also test for other actionable EGFR mutations relevant to the treatment of lung cancer.

These ultra-high sensitivity assays use TBIO’s Multiplexed ICE COLD-PCR (MX-ICP) enrichment technology to generate accurate results from tissue, blood or serum samples, making it feasible to test patients for resistance as treatment proceeds. The EGFR tests are currently available for clinical use through the company’s Oncology CLIA laboratory in Omaha, Nebraska.

TBIO President and CEO Paul Kinnon commented, “We are proud to be the first to offer testing for the EGFR C797S mutation and to do so in flexible formats designed to maximize their utility. This is our 10^th CLIA-certified ICP assay for the detection of actionable cancer mutations, with many more slated for commercial release in the coming months. Our ICP technology is an ideal solution for the repeat DNA testing needed to capitalize on new cancer treatments--it has high sensitivity and requires very small amounts of sample, thereby enabling the liquid biopsies needed for ongoing patient monitoring. These unique ICP CLIA assays provide potentially lifesaving information by enabling the ongoing testing and optimal treatment of lung cancer patients.”

The EGFR C797S assay is intended for NSCLC patients potentially eligible for treatment with third generation EGFR-TKI drugs. The combination of EGFR C797S and T790M markers comprise an acquired resistance panel for EGFR-TKI therapy. EGFR C797S has also been added to the MX-ICP NSCLC (EGFR exons 18 – 21, EGFR C707S, KRAS exons 2 and 3, BRAF exon 15, PIK3CA exons 9 and 20) and the MX-ICP EGFR Analysis (EGFR exons 18 – 21, EGFR C707S) panels to provide comprehensive testing of genetic markers that are key actionable mutations relevant to the treatment of NSCLC. NSCLC is one of the most common types of cancer in the US and is the leading cause of cancer deaths.

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, 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. 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 14, 2016. 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.