The US Food and Drug Administration has approved Thermo Fisher Scientific’s Ion Torrent Oncomine Dx Target Test as a companion diagnostic for identifying patients with HER2-mutated NSCLC who may be eligible for treatment with Bayer’s newly approved therapy, sevabertinib (HYRNUO). This next-generation sequencing (NGS) assay detects HER2/ERBB2 tyrosine kinase domain-activating mutations and provides clinicians and laboratory teams with a validated method to guide therapy selection. Because many diagnostic laboratories support precision oncology workflows, this approval expands access to NGS testing that aligns with an emerging HER2-directed treatment option.
Lung cancer continues to present significant clinical and operational challenges for diagnostic labs, with non-small cell lung cancer accounting for nearly eighty-seven percent of cases worldwide. Companion diagnostics that identify genomic drivers have become central to modern oncology, especially for patients with historically limited treatment options.
FDA approval links targeted therapy and NGS testing
The FDA approved sevabertinib on November 19 to treat adults with locally advanced or metastatic non-squamous NSCLC harboring HER2 TKD activating mutations. The simultaneous authorization of Thermo Fisher’s companion diagnostic ensures clinical labs can immediately offer an assay aligned with the drug’s biomarker requirements. This reduces gaps that often slow the adoption of newly approved oncology therapies.
In the press release, Emmanuelle Di Tomaso, VP and global head of translational sciences oncology at Bayer, stated, “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.” She noted that collaborating with Thermo Fisher allows clinical teams to identify patients “most likely to benefit from sevabertinib, supporting timely and informed treatment decisions in real-world clinical settings.”
Expanding test access through regulatory history and global reimbursement
The Oncomine Dx Target Test was first cleared by the FDA in 2017 as the inaugural NGS-based CDx. Since then, Thermo Fisher has obtained regulatory approvals in 20 countries for 11 biomarkers and more than 20 targeted therapies. According to the company, global reimbursement frameworks—including coverage across the US, Europe, Japan, South Korea, and Israel—make the test accessible to more than 550 million people.
Kathy Davy, president of clinical next-generation sequencing at Thermo Fisher Scientific, said, “The power of precision medicine starts with accurate, timely genomic insights that help providers match patients to the right therapies.” She emphasized that partnering with pharmaceutical companies enables Thermo Fisher to support therapy development, accelerate access, and help clinicians make informed decisions.
In the US, labs can already use the Oncomine Dx Target Test alongside multiple therapies for NSCLC and several additional tumor types, including cholangiocarcinoma, astrocytoma, oligodendroglioma, anaplastic thyroid cancer, medullary thyroid cancer, and other thyroid cancers.
What this means for clinical and molecular laboratories
The approval carries operational significance for molecular diagnostics teams, oncology service lines, and hospital labs integrating NGS into routine testing:
Benefits for laboratory workflows
- Ensures a validated companion diagnostic is available at the time of drug launch
- Reduces reliance on laboratory-developed tests for HER2 TKD mutation detection
- Supports standardization across laboratories performing NGS testing for NSCLC
- Offers clearer reimbursement pathways for HER2 mutation analysis
Implications for patient access
- Expands eligibility screening for a targeted HER2-directed therapy
- Decreases delays associated with test validation or biomarker confirmation
- Helps address gaps that historically caused nearly half of eligible patients to miss targeted treatment opportunities
Key takeaways for lab leaders
For lab managers, this approval illustrates how companion diagnostics continue to influence testing menus, capital planning, and NGS adoption strategies. Adding a clinically validated assay for HER2-mutated NSCLC may streamline test selection, reduce redundant LDT development, and help labs align with oncologists’ precision-medicine workflows. As targeted therapy pipelines grow, leaders in molecular diagnostics will need to evaluate assay performance, throughput, reporting timelines, and reimbursement to support timely patient care.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
