FDA approves cobas EGFR Mutation Test v2 for use with plasma samples, as a companion diagnostic for non-small cell lung cancer therapy- Roche

Roche has announced that the FDA has approved the cobas EGFR Mutation Test v2 for use with plasma samples, as a companion diagnostic for the non-small cell lung cancer (NSCLC) therapy, Tarceva. This is the first FDA approval of a liquid biopsy test as an aid in clinical decisions, and makes the cobas EGFR Mutation Test v2 the only companion diagnostic that is FDA-approved for the detection of the epidermal growth factor receptor (EGFR) gene in DNA derived from plasma or tumor tissue. NSCLC patients who have EGFR exon 19 deletions or L858R mutations are candidates for the EGFR-targeted therapy Tarceva (erlotinib), in first-line treatment.

Comment: according to a recent survey of more than 550 oncologists, EGFR genetic testing is not being conducted in about 25 percent of patients with NSCLC. Currently, many patients do not have the opportunity to be selected for targeted therapies as surgical procedures can be too invasive for very sick patients, travel to surgical locations can be challenging and tumor tissue can be difficult to obtain in sufficient quantity for molecular testing. The FDA approval of the cobas EGFR Mutation Test v2 for use with plasma or tumor tissue will help alleviate barriers to molecular testing by giving clinicians more options for their patients.