FDA Approves First Blood Test to Detect Non-small Cell Lung Cancer

The FDA approved its first blood-based genetic test to detect epidermal growth factor receptor gene mutations in non-small cell lung cancer patients.

The Cobas EGFR Mutation Test v2, manufactured by Roche Molecular Systems, is a blood-based companion diagnostic for the cancer drug Tarceva. The diagnostic detects EGFR gene mutations, present in 10-20 percent of NSCLC patients.

NSCLC tumors shed tumor DNA into a patient’s blood, making it possible to detect specific mutations in a liquid biopsy with minimal invasiveness.

Tarceva, manufactured by Astellas Pharma Technologies, was approved by the FDA in 2004 to treat patients with metastatic NSCLC after failure of at least one prior chemotherapy regimen. In 2013, the FDA approved it for treatment of patients with metastatic non-small cell lung cancer whose tumors having EGFR mutations as detected by an FDA-approved test. — Joya Patel