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FDA approves cobas EGFR Mutation Test v2 for patients with NSCLC

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The FDA approved the cobas EGFR Mutation Test v2 to detect gene mutation associated with non–small cell lung cancer.

The test — a blood-based companion diagnostic for the cancer drug erlotinib (Tarceva; Genentech, Astellas) — is the first FDA–approved, blood-based genetic test that can detect EGFR gene mutations in patients with NSCLC.

A clinical trial evaluated the efficacy of the cobas EGFR Mutation Test v2 (Roche Molecular Systems) using blood samples to identify the EGFR mutation status in patients 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 test will assist in selecting patients who may benefit from treatment with erlotinib. However, the FDA warned if such mutations are not detected in the blood, a tumor biopsy should be performed to determine if the NSCLC mutations are present.

“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 press release. “Liquid biopsies also have the potential to allow physicians to identify patients whose tumors have specific mutations in the least invasive way possible.”