FDA Grants First Liquid Biopsy Approval to the Roche cobas® EGFR Mutation Test v2

Roche launches mobicheck smartphone app

Test can be used with either plasma or tumor tissue, as a companion diagnostic for non-small cell lung cancer therapy

Roche (SIX: RO, ROG; OTCQX, RHHBY) today announced that the U.S. Food and Drug Administration (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.

“The FDA approval of the cobas® EGFR Mutation Test v2 for liquid biopsy for diagnostic use sets a standard in testing for NSCLC patients,” said Uwe Oberlaender, Head of Roche Molecular Diagnostics. “The approval of the test for use with plasma samples means patients who previously could not be tested now have a testing option for personalized healthcare.”

According to a recent survey of more than 550 oncologists, EGFR genetic testing is not being conducted in about 25 percent of patients with NSCLC1,2. 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.

Current clinical guidelines, including the National Comprehensive Cancer Network (NCCN) in the U.S., and the European Society for Medical Oncology (ESMO), recommend EGFR mutation testing in patients with advanced NSCLC, prior to administering targeted therapies.

“The advent of liquid diagnostic platforms in non-small cell lung cancer is truly a game changer in the diagnostic workup of advanced stage patients. The ability to both isolate and genetically interrogate tumor DNA from a simple, minimally invasive test that can subsequently inform treatment decisions is a win for both physician and patient,” said Dr. Benjamin Levy, MD, Director of Thoracic Medical Oncology, Mount Sinai Health Systems and Hospital. “These platforms have the potential to expedite care and potentially circumvent an otherwise cumbersome process of procuring tissue (biopsy) often fraught with complications and complexity.”

View the full press release here.