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SEPTEMBER 30, 2016

Blood-Based T790M Companion Diagnostic Test for Tagrisso Approved

Diagnostic: cobas EGFR (epidermal growth factor receptor) Mutation Test v2 (Roche Molecular)

Status: Approved as a blood-based companion diagnostic for osimertinib (Tagrisso, AstraZeneca) to provide an alternative way of identifying non-small cell lung cancer (NSCLC) patients with metastatic EGFR T790M mutation–positive NSCLC at disease progression

Significant Data:

  • Defined EGFR mutations are detected using DNA isolated from formalin-fixed paraffin-embedded tumor tissue (FFPET) or