Transgenomic Launches EGFR-C797S Mutation Assays to Predict Lung Cancer TKI Resistance

Transgenomic, Inc. has announced the commercial availability of assays to detect EGFR C797S mutation, a mechanism of acquired lung tumor resistance to third-generation tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC).

The assays use targeted PCR amplification to detect NSCLC mutations in tumor tissue and circulating tumor DNA in blood or serum, allowing repeated testing during treatment for timely detection of acquired drug resistance. The tests are performed at Transgenomic’s Oncology CLIA lab in Omaha.

The C797S test is available as a solo assay and is also included in three panel tests: Transgenomic’s “EGFR-TKI resistance” panel (which tests for acquired C797S and T790M mutations), the more extensive Multiplexed ICE COLD-PCR (MX-ICP) circulating tumor-DNA EGFR NSCLC panel (which tests for mutations at EGFR exons 18, 19, 20, 21, as well as KRAS, BRAF, and PIK3CA exons), and the “MX-ICP EGFR Analysis” panel, which tests for several actionable EGFR exons 18-21 mutations in lung cancer.

The tests are intended for NSCLC patients who may be candidates for treatment with third-generation EGFR-TKI drugs.

The tests represent “an ideal solution for the repeat DNA testing needed to capitalize on new cancer treatments,” according to Transgenomic President and CEO Paul Kinnon. The test has “high sensitivity and requires very small amounts of sample, thereby enabling the liquid biopsies needed for ongoing patient monitoring,” he was quoted as saying in a press release.

Transgenomic holds an exclusive license for ICP testing, which was developed at Dana-Farber Cancer Institute.