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China's NMPA Extends Approval for Roche Cobas EGFR Mutation Test v2 to Plasma Samples

NEW YORK – China's National Medical Products Administration (NMPA) recently extended approval of the Roche Cobas EGFR Mutation Test v2 to include the use of plasma samples for the detection of EGFR mutations in patients with non-small cell lung cancer, according to a Roche spokesperson.

Previously, the test was only approved for use with tumor tissue samples. Labs and clinicians in China can now use the Cobas EGFR Mutation Test v2 with either tissue or plasma samples as a companion diagnostic for three oncology drugs — erlotinib (Genentech/Astellas' Tarceva), osimertinib (AstraZeneca's Tagrisso), and gefitinib (AstraZeneca's Iressa) — for the first-line treatment of NSCLC patients whose tumors have EGFR exon 19 deletions or exon 21L858R mutations. In addition, the test can be used with either sample type as a CDx for osimertinib for second-line treatment and beyond in NSCLC patients who test positive for the EGFR T790M mutation.

Roche said that the extended approval, granted by the NMPA on June 26, significantly expands patient access to Cobas EGFR mutation testing by including patients who are not eligible for tissue biopsy. In addition, the workflow for the test enables patients and clinicians to obtain results in as little as one day.