Posted by Michael Wonder on 15 Aug 2025
Thermo Fisher receives FDA approval for NGS based companion diagnostic for new non-small cell lung cancer treatment
11 August 2025 - Thermo Fisher Scientific has received approval from the US FDA for its Oncomine Dx Target Test as a companion diagnostic to identify patients who may be candidates for Hernexeos (zongertinib tablets), a tyrosine kinase inhibitor, developed by Boehringer Ingelheim.
The test allows clinicians and pathologists to assess if non-small cell lung cancer tumours harbour human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain activating mutations.
