- The Food and Drug Administration on Wednesday approved a new blood test from Roche which detects a specific mutation found in between 10% and 20% of patients with non-small cell lung cancer.
- Roche's liquid biopsy diagnostic tests for the presence of tumor DNA in a patient's blood and is the first FDA-approved test that can detect the presence of epidermal growth factor receptor (EGFR) gene mutations.
- The cobas EGFR Mutation Test v2 was approved as a companion diagnostic for the lung cancer drug Tarceva, which is marketed by the Japanese drugmaker Astellas.
Non-small cell lung cancer tumors "shed" tumor DNA into the bloodstream, which makes such a liquid biopsy test possible. Typically, a tumor biopsy would be performed to determine whether certain mutations are present. With Roche's new diagnostic, patients who are too ill to provide a tumor specimen can still be tested.
A liquid biopsy test can also help make treatment more personalized and less invasive overall.
"Liquid biopsies also have the potential to allow physicians to identify patients whose tumors have specific mutations in the least invasive way possible," said Alberto Gutierrez, director of the FDA's Office of In Vitro Diagnostics and Radiological Health.
Astellas' drug, Tarceva, was originally approved by the FDA in 2004 as a second-line treatment for NSCLC, and received a broader indication to treat specific EGFR-related mutations in 2013.
Roughly 221,200 Americans will receive a lung cancer diagnosis this year, and 158,040 will die from the disease, according to the National Cancer Institute.
The approval of Roche's test also fits into a growing emphasis on better targeting cancer treatments to the patients who can benefit the most. New cancer immunotherapies from Merck and Roche have also been paired with tests capable of detecting specific proteins typically expressed on tumor cells.