FDA Approves First NGS-Based Companion Diagnostic to Aid in Selecting Non-Small Cell Lung Cancer Patients with HER2 (ERBB2) Activating Mutations (SNVs & Exon 20 Insertions) for Treatment with ENHERTU

CARLSBAD, Calif.–(BUSINESS WIRE)–The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients whose tumors have a HER2 (ERBB2) activating mutations (SNVs & Exon 20 Insertion) in non-small cell lung cancer (NSCLC) who may be candidates for ENHERTU® (fam-trastuzumab deruxtecan-nxki). ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jo
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