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. Lung cancer remains the leading cause of cancer death worldwide, with NSCLC representing approximately 87% 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. Historically, nearly 50% of eligible patients miss out on targeted therapies due to testing and report delays, access limitations or lab bottlenecks, creating gaps that hinder precision medicine progress.

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). 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 targets 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).