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# FDA Approves Roche’s Cobas EGFR Mutation Test in Lung Cancer Patients
- URL: https://www.fdaweb.com/fda-approves-roches-cobas-egfr-mutation-test-in-lung-cancer-patients/
- Published: 2016-06-01T12:00:00.000Z
- Updated: 2026-09-14T21:06:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135811

FDA has approved Roche’s cobas EGFR Mutation Test v2, a companion diagnostic for the cancer drug Tarceva (erlotinib) that is the first blood-based genetic test detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients, according to an agency [release](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm504488.htm?ref=fdaweb.com). “With the cobas EGFR Mutation Test v2,” the release says, “the presence of specific NSCLC mutations \[exon 19 deletion or exon 21 (L858R) substitution mutations\] detected in patients’ blood samples aids in selecting those who may benefit from treatment with Tarceva. However, if such mutations are not detected in the blood, then a tumor biopsy should be performed to determine if the NSCLC mutations are present.”

FDA approved [Tarceva](http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2004/ucm108378.htm?ref=fdaweb.com) in 2004 to treat patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen, and in 2013 it was given expanded approval as a first-line treatment for patients with metastatic non-small cell lung cancer whose tumors having EGFR exon 19 deletions or L858R substitution mutations as detected by an FDA-approved test.