Thermo Fisher Scientific has received U.S. FDA approval for its Oncomine Dx Target Test as a companion diagnostic (CDx) for HERNEXEOS® (zongertinib tablets), developed by Boehringer Ingelheim. The test helps identify patients with non-small cell lung cancer (NSCLC) whose tumors harbor HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations.
Lung cancer is the second most common cancer in the U.S., with NSCLC making up 85–90% of cases. HER2 mutations occur in about 2–4% of NSCLC patients and are linked to poor prognosis. The FDA approved HERNEXEOS on August 8, 2025, as the first and only oral targeted therapy for adults with unresectable or metastatic HER2-mutant non-squamous NSCLC who have received prior systemic therapy. The approval was granted under the accelerated approval pathway, with continued authorization dependent on confirmatory trial results.
Thermo Fisher’s Oncomine Dx Target Test, first approved in 2017, is an NGS-based diagnostic with regulatory clearance in 20 countries for 11 biomarkers and over 20 targeted therapies. It is reimbursed in multiple regions, covering more than 550 million lives worldwide. In the U.S., it is approved for targeted therapies in NSCLC and several other cancers.