12 August 2022 - This approval marks the Oncomine Dx Target Test’s eighth companion diagnostic therapy selection indication
The U.S. FDA has granted pre-market approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to identify patients whose tumours have a HER2 (ERBB2) activating mutations (SNVs & exon 20 insertion) in non-small-cell lung cancer who may be candidates for Enhertu (fam-trastuzumab deruxtecan-nxki).