On June 1, 2016, the FDA approved Roche Holding AG's cobas® EGFR Mutation Test v2 as a companion diagnostic for Astellas Pharma Inc.'s Tarceva® (erlotinib), a non-small cell lung cancer (NSCLC) therapy. This is the first FDA-approved, blood-based genetic test (also called a liquid biopsy) to detect epidermal growth factor receptor (EGFR) gene mutations, which are present in 10-20% of NSCLC patients.

When NSCLC tumors shed DNA into the bloodstream, specific mutations can be detected in blood samples. By performing a liquid biopsy, the cobas® EGFR Mutation Test v2 can, with minimal invasion, diagnose NSCLC patients who cannot have traditional biopsies.

According to the National Cancer Institute (NCI), lung cancer is the leading cause of cancer-related death in the US, with NSCLC being the most common type. The NCI estimates that there will be 221,200 new diagnoses and 158,040 deaths from lung cancer this year.

Sources: FDA: FDA Approves First Blood Test to Detect Gene Mutation Associated with Non-Small Cell Lung Cancer, June 1, 2016 and Roche: FDA Grants First Liquid Biopsy Approval to the Roche cobas® EGFR Mutation Test v2, June 1, 2016.