FDA grants first Liquid Biopsy approval to the Roche cobas EGFR Mutation Test v2


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 NSCLC.1,2 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.


About the cobas® EGFR Mutation Test v2


The cobas® EGFR Mutation Test v2 is built upon the success of the cobas® EGFR Mutation Test available globally today, with expanded mutation coverage that identifies 42 EGFR mutations in exons 18-21, including L858R, exon 19 deletions, and T790M. The test is performed on the cobas® 4800 System, which offers high-performance polymerase chain reaction (PCR) amplification and detection coupled with software that automates results interpretation and reporting. The cobas® 4800 System menu for diagnostic use in oncology includes the cobas® EGFR Mutation Test v2, the cobas® EGFR Mutation Test, the cobas® KRAS Mutation Test, and the 4800 BRAF V600 Mutation Test. Tarceva is developed and commercialized by Astellas Pharma US in partnership with Genentech in the United States, Chugai in Japan and Roche in the rest of the world.


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  1. 2015 European Lung Cancer Conference (ELCC): Abstract LBA2_PR. Presented April 17, 2015
  2. Davenport, Liam, “EGFR Testing Not Done in 25% of Lung Cancer Patients.” Medscape Medical News, April 17, 2015
cobas EGFR product box

cobas® EGFR Mutation Test v2

The cobas® EGFR Mutation Test v2 is a real-time PCR test that identifies 42 mutations in exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene, including the T790M resistant mutation.