FDA Approves EGFR Mutation Test as Companion Diagnostic in Non-Small Cell Lung Cancer


FDA approves the cobas EGFR Mutation Test v2 as a companion diagnostic for EGFR TKIs in the treatment of EGFR-mutated non–small cell lung cancer.

The FDA has approved the cobas EGFR Mutation Test v2 as a companion diagnostic for EGFR TKIs in the treatment of patients with EGFR-mutated non­—small cell lung cancer (NSCLC), according to an announcement from Roche, the test developer.1

This test is indicated for use as a companion diagnostic to aid in the detection of EGFR mutations in both tissue and plasma samples collected from patients with NSCLC. With cobas EGFR Mutation Test v2, results are made available in less than 8 hours, according to Roche. With the new approval, this is the first companion diagnostic test for expanded EGFR therapies in this disease.

Specifically, the claim expansion allows for the assay to be used for all of the currently FDA-approved EGFR TKIs targeting the EGFR mutations L858R and exon 19 deletions per the approved therapeutic product labeling. The claim will also allow for the test to be used as a companion diagnostic for any EGFR TKI targeting those same alterations that receives approval in the future without the need for individual clinical studies with the test to be conducted for each new therapy.

“Clinicians can now have greater confidence in the robustness, reliability, and proven clinical utility of the cobas EGFR Mutation Test v2 when evaluating [patients with] lung cancer who may benefit from targeted EGFR TKI therapies,” Neil Gunn, head of Sequencing Solutions at Roche.

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