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# FDA OKs Label Extension for Tagrisso Companion Diagnostic
- URL: https://www.fdaweb.com/fda-oks-label-extension-for-tagrisso-companion-diagnostic/
- Published: 2016-09-29T12:00:00.000Z
- Updated: 2026-09-14T21:35:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136941

FDA has approved a label extension for Roche’s EGFR Mutation Test v2 for use with plasma samples as a companion diagnostic for Astra Zeneca’s Tagrisso (osimertinib), which is indicated for patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). The test uses either tissue or a blood sample to confirm the presence of a T790M mutation in patients who have progressed on or after an EGFR tyrosine kinase inhibitor (TKI) medicine. “The approval provides a new, non-invasive option to identify patients with metastatic EGFR T790M mutation-positive NSCLC, ensuring that those patients who may not be suitable for biopsy procedures have an opportunity to be tested,” AstraZeneca says. “Blood-based testing for the presence of the mutation is recommended only when a tumor biopsy cannot be obtained. Patients who test negative for the T790M mutation with the blood-based test, and their physicians, should re-evaluate the feasibility of tissue-based testing to confirm the presence of the EGFR T790M mutation.”