Test will serve as a companion diagnostic for Bayer’s HYRNUO™ (sevabertinib) to identify patients with NSCLC eligible for HER2-targeted therapy

Thermo Fisher Scientific, the world leader in serving science, 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.

Lung cancer remains the leading cause of cancer death worldwide, with NSCLC representing approximately 87 percent of all lung cancer cases.¹ For patients with NSCLC presenting with HER2 mutations, this approval represents an opportunity to provide more targeted treatment for a disease that has traditionally had limited therapeutic options as well as poor prognosis with a survival rate of less than 10% for metastatic disease.² Historically, nearly 50% of eligible patients miss out on targeted therapies due to testing and report delays, access limitations or lab bottlenecks³, creating gaps that hinder precision medicine progress.

“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.”

The Oncomine Dx Target Test received its first approval by the FDA as a next-generation sequencing (NGS) CDx in 2017, followed by regulatory approvals in 20 countries for 11 biomarkers and over 20 targeted therapies (availability of these approvals vary per region).

“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.”

Broad reimbursement coverage—including the U.S., Europe, Japan, South Korea, and Israel—makes the Oncomine Dx Target Test accessible to more than 550 million people worldwide. In the U.S., the Oncomine Dx Target Test is authorized for use alongside multiple therapies for NSCLC and a range of other tumor types, such as cholangiocarcinoma (CC), astrocytoma (AC) and oligodendroglioma (OG), anaplastic thyroid cancer (ATC), medullary thyroid cancer (MTC), and thyroid cancer (TC).