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

Thermo Fisher

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).

Read Thermo Fisher press release

Michael Wonder

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Michael Wonder

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Cancer , Outcome , US , Diagnostic agent