November 21, 2025- Thermo Fisher Scientific has received approval from the U.S. Food and Drug Administration (FDA) for its Ion Torrent™ Oncomine™ Dx Target Test as a companion diagnostic (CDx) to identify patients who may be eligible for treatment with HYRNUO™ (sevabertinib), a new HER2-directed therapy developed and commercialized by Bayer. The test enables clinicians and pathologists to identify non-small cell lung cancer (NSCLC) tumors with certain HER2/ERBB2 tyrosine kinase domain (TKD) activating mutations, helping determine which patients may benefit from HYRNUO™ therapy.
The FDA also approved HYRNUO™ on November 19 for the treatment of adult patients with locally advanced or metastatic non-squamous NSCLC harboring HER2 TKD activating mutations. The contemporaneous approval of Bayer’s therapy and Thermo Fisher’s companion diagnostic helps close access gaps, ensuring labs have access to essential companion testing as soon as the drug is available.