The EGFR C797S Mutation Detection Assay is based on the company’s ICE COLD-PCR (ICP) technology. Currently, the test is available for clinical use via the company’s Biomarker Discovery Services group.

The assay is anticipated to available for clinical use through the firm’s Oncology CLIA laboratory in Omaha, Nebraska later this year.

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."

"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.

The firm also produces assay for EGFR T790M mutation, a known marker for resistance in first generation TKI therapies.

Last September, Australia’s University of Melbourne received a license from biotechnology firm Transgenomic to use its Multiplexed ICE COLD-PCR (MX-ICP) technology for several research and clinical applications.