The Food and Drug Administration has approved the Cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor gene mutations in non-small cell lung cancer patients, which are present in about 10 to 20 percent of such cancers.
“Approvals of liquid biopsy tests make it possible to deliver highly individualized health care for patients,” Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement. “Liquid biopsies also have the potential to allow physicians to identify patients whose tumors have specific mutations in the least invasive way possible.”
With the Cobas EGFR Mutation Test v2, the presence of specific NSCLC mutations—exon 19 deletion or exon 21 (L858R) substitution mutations—detected in patients’ blood samples aids in selecting those who may benefit from treatment with Tarceva. However, if such mutations are not detected in the blood, then a tumor biopsy should be performed to determine if the NSCLC mutations are present. Insofar as the test provides positive results, it may benefit patients who may be too ill or are otherwise unable to provide a tumor specimen for EGFR testing.
The efficacy of the Cobas EGFR Mutation Test v2 using blood samples was determined by using the test to identify the EGFR mutation status in patients enrolled into a clinical trial whose tumor biopsies were previously confirmed positive for the EGFR exon 19 deletion or L858R mutations as determined by the cobas EGFR Mutation Test v1. The cobas EGFR Mutation Test v2 is manufactured by Roche Molecular Systems in
The FDA approval “sets a standard in testing for NSCLC patients,” Uwe Oberlaender, head of Roche Molecular Diagnostics, said in a statement. “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 health care.”
EGFR genetic testing is not being conducted in about 25 percent of patients with NSCLC, said a survey of more than 550 oncologists presented at the 2015 European Lung Cancer Conference. Clinical guidelines, including those published by the National Comprehensive Cancer Network in the U.S. and the European Society for Medical Oncology, 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,” Benjamin Levy, MD, director of thoracic medical oncology at Mount Sinai Health Systems and Hospital, said in a Roche statement. “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. 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.”