Thermo Fisher Scientific, a global leader in serving science, has secured U.S. Food and Drug Administration (FDA) approval for its Ion Torrent™ Oncomine™ Dx Target Test as a companion diagnostic (CDx) for identifying patients eligible for HYRNUO™ (sevabertinib). HYRNUO™, developed and commercialized by Bayer, is a newly approved HER2-directed therapy. The diagnostic test enables clinicians and pathologists to detect specific HER2/ERBB2 tyrosine kinase domain (TKD) activating mutations in non-small cell lung cancer (NSCLC), allowing them to determine which patients may benefit from treatment with HYRNUO™.
On November 19, the FDA also approved HYRNUO™ for adult patients with locally advanced or metastatic non-squamous NSCLC harboring HER2 TKD activating mutations. The simultaneous approval of Bayer’s targeted therapy and Thermo Fisher’s CDx ensures that laboratories can access essential testing immediately, helping close long-standing gaps in timely precision oncology.
Lung cancer continues to be the leading cause of cancer mortality worldwide, with NSCLC accounting for nearly 87% of all cases. For patients whose tumors harbor HER2 mutations, this advancement provides a meaningful expansion of targeted treatment options—an area historically characterized by limited therapies and poor outcomes, with metastatic disease survival rates below 10%. Additionally, testing and reporting delays, access issues, and laboratory bottlenecks have traditionally caused nearly 50% of eligible patients to miss out on targeted therapies. This paired approval aims to reduce those barriers.
“We are committed to advancing innovation for patients with difficult-to-treat cancers, and this approval marks another step forward in ensuring all patients with cancer have access to optimal treatment options,” said Emmanuelle Di Tomaso, VP, Global Head of Translational Sciences Oncology at Bayer. “Collaborating with Thermo Fisher to leverage the Oncomine Dx Target Test allows us to ensure clinical teams can identify patients who are most likely to benefit from sevabertinib, supporting timely and informed treatment decisions in real-world clinical settings.”
Initially approved by the FDA in 2017 as a next-generation sequencing (NGS) CDx, the Oncomine Dx Target Test has since expanded to receive regulatory clearance in 20 countries, covering 11 biomarkers and more than 20 targeted therapies (regional availability varies).
“The power of precision medicine starts with accurate, timely genomic insights that help providers match patients to the right therapies,” said Kathy Davy, president of clinical next-generation sequencing at Thermo Fisher Scientific. “Our experience as a companion diagnostics partner of choice for pharmaceutical companies allows us to support the development of new therapies, accelerate access and help clinicians make the best possible decisions for their patients.”
