Roche today announced it has received approval from the U.S. Food and Drug Administration (FDA) of its Premarket Approval (PMA) supplement for the cobas® EGFR Mutation Test v2 to be used as a companion diagnostic test (CDx) with Tagrisso for first line treatment of patients diagnosed with metastatic NSCLC whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations. A companion diagnostic test is a medical device which provides information that is essential for the safe and effective use of a corresponding therapeutic product.
Clinical studies have demonstrated that patients diagnosed with NSCLC who test positive for defined mutations of the epidermal growth factor receptor (EGFR) gene benefit from tyrosine kinase inhibitor (TKI) therapies. The cobas® EGFR Mutation Test v2 was previously FDA-approved as a companion diagnostic test with Tagrisso for second line treatment and beyond in NSCLC patients who test positive for the EGFR T790M mutation. The test is also a companion diagnostic test with Tarceva (erlotinib) for NSCLC patients who test positive for the EGFR exon 19 deletion or L858R sensitizing mutations.
Approvals thus far are for both tissue and liquid (patient blood plasma) biopsy. EGFR testing in plasma offers a non-invasive option for patients using a simple blood draw for those who are not eligible for a tissue biopsy. In addition, the workflow for cobas EGFR Mutation Test v2 enables patients and clinicians to obtain results in as little as one day.
"The ability to provide confident patient test results in less than one day from sample preparation to report, provides clinicians the information necessary to choose the optimal therapy and avoid delays in getting their patients started on treatment," said Sid Scudder, MD, Senior Director, Clinical Research, Genomics & Oncology, Roche Molecular Diagnostics.
The cobas EGFR Mutation Test v2 is a real-time PCR (polymerase chain reaction) test for the qualitative detection of 42 defined mutations of the EGFR gene in exons 18-21, including L858R, exon 19 deletions, and T790M mutations. This in-vitro diagnostic (IVD) test is the first and currently the only FDA-approved EGFR test to include both tissue and liquid biopsy (plasma) as patient sample types for testing.