Latest in Transgenomic’s Pipeline of CLIA Tests that Leverage the Outstanding Sensitivity of its Multiplexed ICE COLD-PCR™, Conforms to ASCO and NCCN Testing Recommendations
OMAHA, Neb. (August 19, 2015) — Transgenomic, Inc. (NASDAQ: TBIO) today announced the launch of its MX-ICP EGFR Analysis lung cancer panel that covers key actionable mutations while providing precision detection levels down to as low as 0.01%. The panel uses Transgenomic’s Multiplexed ICE COLD-PCR™ (MX-ICP) technology, which generates highly accurate results from small amounts of blood or tissue samples and is available for diagnostic use through the company’s CLIA laboratory. The panel adds to the mutations included in the company’s first EGFR tests launched in May, adding mutations in EGFR exons 18-21 that are associated with resistance to tyrosine kinase inhibitor (TKI) cancer drugs and broadening the testing options available to the oncologist. Transgenomic’s EGFR panels address all of the known mutations that affect EGFR status and the likely efficacy of TKI drugs for the patient’s cancer.
Characteristic mutations in the epidermal growth factor receptor (EGFR) are found in many patients with lung tumors, and these mutations may be associated with susceptibility or resistance to certain targeted cancer drugs. For example, 85% of EGFR mutations in patients with non-small cell lung cancer (NSCLC) indicate that the tumor is sensitive to TKI’s1, while a different EGFR mutation is associated with resistance to TKIs2. Transgenomic’s EGFR panels include all the mutations listed in the guidelines for EGFR mutation testing issued by the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN).
“The launch of this new EGFR panel soon after the debut of our first CLIA cancer tests reflects our commitment to making our Multiplexed ICE COLD-PCR-based tests widely available to patients,” said Paul Kinnon, President and CEO of Transgenomic. “The new panel extends and broadens the utility of our initial EGFR tests, by now including all of the actionable EGFR mutations that are currently known to affect the utility of targeted therapies for lung and colorectal cancer, such as tyrosine kinase inhibitors. Our MX-ICP technology produces highly accurate results that require only small amounts of blood, making it especially suitable for ongoing patient monitoring over the entire course of the patient’s treatment. We look forward to adding additional tests and panels to our suite of CLIA mutation detection tests in the coming months.
Transgenomic’s first EGFR tests were for the detection of EGFR exon 20 T790M mutations that indicate if the NSCLC tumor has developed resistance to TKI drugs and EGFR exon 12 S492R mutations that render colorectal tumors resistant to cetuximab. The new MX-ICP EGFR Analysis panel includes EGFR exons 18-21 to determine NSCLC tumor sensitivity or resistance to tyrosine kinase inhibitors.
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 of plasma sample, making it possible to obtain accurate and sensitive biopsies using either liquid or solid tissue specimens. 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.
Additional tests and panels for mutations in KRAS, NRAS, PIK3CA, BRAF and other genes are in development.
For more information on Transgenomic’s EGFR CLIA tests, click here.
1 Prabhakar, Charles. Epidermal growth factor receptor in non-small cell lung cancer. Transl Lung Cancer Res 2015; 4(2):110-118.
2 NCCN NSCLC Clinical Guidelines. http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf
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. The company 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.