Transgenomic, Inc., a global biotechnology company, 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 per cent.

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 tumours, and these mutations may be associated with susceptibility or resistance to certain targeted cancer drugs. For example, 85 per cent 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 tumour has developed resistance to TKI drugs and EGFR exon 12 S492R mutations that render colorectal tumours resistant to cetuximab. The new MX-ICP EGFR Analysis panel includes EGFR exons 18-21 to determine NSCLC tumour 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 per cent 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.