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# FDA Approves Roche’s Test for Iressa
- URL: https://www.fdaweb.com/fda-approves-roches-test-for-iressa/
- Published: 2018-08-23T12:00:00.000Z
- Updated: 2026-09-15T00:27:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142188

FDA has approved Roche’s cobas EGFR Mutation Test v2 as a companion diagnostic test for selecting patients suitable for AstraZeneca’s Iressa (gefitinib) in treating non-small cell lung cancer (NSCLC). The cobas test is currently the only FDA-approved diagnostic test for NSCLC using liquid biopsy. Epidermal growth factor receptor (EGFR) testing in plasma offers a non-invasive option for patients using a simple blood draw for those who are not eligible for a tissue biopsy, the company says. The real-time polymerase chain reaction test provides qualitative detection of 42 defined mutations of the EGFR gene in exons 18-21, including L858R, exon 19 deletions, and T790M mutations.