Aug. 11, 2025—Thermo Fisher Scientific has received FDA approval for its Oncomine Dx Target test as a companion diagnostic to identify patients who may be candidates for zongertinib (Hernexeos, Boehringer Ingelheim), a tyrosine kinase inhibitor. The test allows clinicians and pathologists to assess if non-small cell lung cancer tumors harbor HER2/ERBB2 tyrosine kinase domain activating mutations.
The FDA granted accelerated approval to Hernexeos for adults with unresectable or metastatic NSCLC whose tumors have HER2 (ERBB2) TKD-activating mutations, as detected by an FDA-approved test and who have received prior systemic therapy.