Thermo Fisher Scientific has received authorization from the United States Food and Drug Administration for the Ion Torrent Oncomine Dx Target Test as a companion diagnostic for patients who may be eligible for treatment with sevabertinib, a newly approved HER2-directed therapy developed by Bayer. The diagnostic assay is designed to detect specific activating mutations within the HER2 and ERBB2 tyrosine kinase domains in non small cell lung cancer. Identification of these variants enables clinicians to determine which patients may be appropriate candidates for sevabertinib therapy.
The FDA issued its approval of sevabertinib on November 19 for adults with locally advanced or metastatic non squamous non small cell lung cancer that harbors HER2 tyrosine kinase domain activating mutations. The parallel authorization of both the therapeutic and its companion test is intended to reduce delays in access and to ensure that laboratories can perform the required genomic analysis immediately after the therapy becomes available.
Non small cell lung cancer accounts for the large majority of lung cancer cases globally and lung cancer overall remains the leading cause of cancer related mortality. HER2 driven forms of the disease represent a subgroup for which treatment options have historically been limited and survival outcomes for metastatic disease remain poor, with reported rates below ten percent. Clinical experts note that nearly half of patients who could benefit from targeted agents frequently fail to receive them due to testing delays, reporting barriers or laboratory capacity constraints.
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. 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.
Emmanuelle Di Tomaso, VP, Global Head of Translational Sciences Oncology at Bayer
The Oncomine Dx Target Test originally received FDA authorization in 2017 as a next generation sequencing companion diagnostic and has since gained regulatory clearance in multiple regions for numerous biomarkers and targeted therapies. Thermo Fisher Scientific reports that the platform now supports a wide array of oncology indications.
The power of precision medicine starts with accurate, timely genomic insights that help providers match patients to the right therapies. 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.
Kathy Davy, president of clinical next-generation sequencing at Thermo Fisher Scientific
The test is currently reimbursed across several major markets including the United States, Europe, Japan, South Korea and Israel, which collectively account for more than 550 million covered individuals. Within the United States the assay is authorized for companion diagnostic use not only in non small cell lung cancer but also in several additional tumor types including cholangiocarcinoma, astrocytoma, oligodendroglioma, anaplastic thyroid cancer, medullary thyroid cancer and other thyroid malignancies.