Thermo Fisher Scientific Secures FDA Approval for NGS-Based Companion Diagnostic to Support New HER2-Targeted NSCLC Therapy
Thermo Fisher Scientific Inc. (NYSE: TMO), the global leader in serving science, has announced a significant regulatory milestone with the U.S. Food and Drug Administration’s (FDA) approval of its Oncomine Dx Target Test as a companion diagnostic (CDx) for the newly approved non-small cell lung cancer (NSCLC) therapy HERNEXEOS® (zongertinib tablets) from Boehringer Ingelheim. The test’s expanded indication will enable oncologists, pathologists, and molecular laboratories to identify patients whose tumors carry human epidermal growth factor receptor 2 (HER2, also known as ERBB2) tyrosine kinase domain (TKD) activating mutations—patients who may be eligible for treatment with HERNEXEOS.
This approval marks another step forward in precision oncology, where the identification of specific genetic mutations guides the selection of targeted treatments, offering patients a higher chance of benefit while avoiding therapies unlikely to work for their cancer type.
Understanding the Context: Lung Cancer and HER2 Mutations
Lung cancer remains one of the most pressing public health challenges in oncology. In the United States, it is the second most commonly diagnosed cancer in both men and women, following prostate cancer in men and breast cancer in women. According to the American Cancer Society, lung cancer is also the leading cause of cancer-related deaths globally, underscoring the urgent need for improved detection and treatment strategies.
Non-small cell lung cancer (NSCLC) accounts for approximately 85% to 90% of all lung cancer cases. Within NSCLC, several molecular subtypes are defined by specific genetic alterations—such as EGFR mutations, ALK rearrangements, ROS1 fusions, KRAS mutations, and, more rarely, HER2 mutations.
HER2 mutations in NSCLC are relatively uncommon, appearing in 2% to 4% of patients. These mutations are distinct from the well-known HER2 amplifications or overexpression commonly seen in breast and gastric cancers. In NSCLC, HER2 alterations typically involve mutations in the tyrosine kinase domain of the receptor, which can drive tumor growth and progression. Historically, there have been no FDA-approved targeted therapies specifically addressing HER2-mutant NSCLC—leaving these patients with limited options after progression on standard chemotherapy or immunotherapy.
The FDA’s Approval of HERNEXEOS
On August 8, 2025, the FDA granted accelerated approval for HERNEXEOS® (zongertinib tablets), making it the first and only orally administered targeted therapy for adult patients with unresectable or metastatic non-squamous NSCLC whose tumors harbor HER2 (ERBB2) TKD activating mutations. Eligible patients must have received prior systemic therapy before starting HERNEXEOS, and their mutation status must be confirmed using an FDA-approved diagnostic test—such as the Oncomine Dx Target Test.
The Thermo Fisher drug’s approval under the FDA’s Accelerated Approval Program was based on data demonstrating meaningful objective response rates (ORR) and duration of response (DoR) in this patient population. Accelerated approval enables earlier patient access to promising therapies for serious conditions, with the requirement that confirmatory trials verify the anticipated clinical benefits. Continued marketing authorization for HERNEXEOS will be contingent upon these confirmatory trial results.
Detailed prescribing information, including dosing guidelines, safety data, and patient selection criteria, is available at HERNEXEOS.com.
Why This Is a Significant Advancement
“This rare form of non-small cell lung cancer is linked to a poor prognosis and limited treatment options, making HERNEXEOS an important advancement in addressing the unmet needs of patients,” said Vicky Brown, Senior Vice President and Head of Immunology, Oncology, and Eye Health at Boehringer Ingelheim.
Brown emphasized the strategic value of the collaboration with Thermo Fisher, noting that the availability of a validated companion diagnostic is critical for identifying eligible patients efficiently. “Through our collaboration with Thermo Fisher and leveraging the company’s proven track record with companion diagnostics, we’re pleased that patients have another tool that can be used to identify those with HER2 (ERBB2) tyrosine kinase activating mutations in non-small cell lung cancer,” she added.
HER2-mutant NSCLC patients often have a poor prognosis compared with those without the mutation, partly because the disease tends to be aggressive and partly because of the historical lack of targeted treatment options. The availability of both a targeted therapy and a validated CDx helps close this long-standing gap in care.
Oncomine Dx Target Test: A Pioneer in NGS-Based Companion Diagnostics
The Thermo Fisher Oncomine Dx Target Test is a next-generation sequencing (NGS) assay that detects multiple genomic variants across a range of cancer-relevant genes. Since its first FDA approval in 2017, the platform has expanded considerably:
- Regulatory reach: Approved in 20 countries for 11 biomarkers linked to more than 20 targeted therapies.
- Global coverage: Reimbursed by government and commercial insurers in the U.S., Europe, Japan, South Korea, and Israel—covering over 550 million lives worldwide.
- Multiple cancer types: In the United States, the test is approved for use in NSCLC, cholangiocarcinoma (CC), astrocytoma (AC), oligodendroglioma (OG), anaplastic thyroid cancer (ATC), medullary thyroid cancer (MTC), and thyroid cancer (TC).
The technology behind the Oncomine Dx Target Test allows for the simultaneous analysis of DNA and RNA from tumor tissue, enabling detection of point mutations, insertions, deletions, copy number variations, and gene fusions in a single workflow. This multiplexing capability means that patients can be screened for multiple actionable mutations without needing multiple separate tests, saving both time and tissue—critical considerations in oncology.
Rapid Turnaround and Expanding Capabilities
According to Kathy Davy, President of Clinical Next-Generation Sequencing at Thermo Fisher Scientific, the FDA’s green light for the test’s expanded use reaffirms the company’s commitment to timely and accessible molecular diagnostics.
“The Thermo Fisher FDA’s approval of HERNEXEOS for previously treated patients living with HER2 (ERBB2)-mutant advanced non-small cell lung cancer signifies continued success in our efforts to develop timely and accessible companion diagnostics,” Davy said. “We’re continuing to expand our solutions for our pharma partners, as this approval quickly follows the recent FDA approval of our latest rapid NGS solution that can deliver results in as little as 24 hours.”
A shorter Thermo Fisher turnaround time for NGS results is particularly important for patients with advanced cancers, where treatment decisions must often be made quickly to avoid disease progression.
How Companion Diagnostics Improve Cancer Care
Companion diagnostics are laboratory tests designed to determine whether a patient is likely to benefit from a particular drug. They Thermo Fisher are integral to the precision medicine model of cancer treatment. In the case of HER2-mutant NSCLC, the Oncomine Dx Target Test serves as a gatekeeper, ensuring that only those patients whose tumors harbor the specific mutation are prescribed HERNEXEOS—thereby maximizing the potential for benefit while minimizing exposure to unnecessary drug toxicity in patients unlikely to respond.
For oncologists, Thermo Fisher having a validated CDx means greater confidence in their treatment decisions. For patients, it means a higher likelihood that the treatment they receive is tailored to the biology of their disease.
A Closer Look at HER2 in Lung Cancer
While HER2 has been a well-established target in breast and gastric cancers, its role in lung cancer has only become clearer in recent years. In NSCLC, HER2 alterations typically take the form of:
- Point mutations in the tyrosine kinase domain (most common in lung cancer)
- Insertions in exon 20
- Less commonly, amplifications or overexpression
Unlike HER2-positive breast cancer, where monoclonal antibodies like trastuzumab have been highly effective, HER2-mutant lung cancers have proven resistant to many HER2-directed therapies developed for other tumor types. This Thermo Fisher resistance has fueled the search for more effective HER2-specific targeted therapies for lung cancer—culminating in the development of TKIs like zongertinib.
Industry Impact and Future Directions
The dual approval of HERNEXEOS and the Oncomine Dx Target Test’s expanded indication represents another win for the co-development model between pharmaceutical companies and diagnostic technology providers. In oncology, such partnerships are becoming increasingly common, as the success of a targeted therapy often depends on the ability to accurately and rapidly identify eligible patients.
Thermo Fisher’s CDx platform is already widely used in cancer centers and molecular pathology labs worldwide, Thermo Fisher meaning the infrastructure to deploy this new indication is largely in place. This could accelerate adoption and ensure that more patients are tested promptly after diagnosis or disease progression.
Looking ahead, Boehringer Ingelheim will continue confirmatory clinical trials for HERNEXEOS to secure full FDA approval, while Thermo Fisher is likely to pursue additional biomarker indications for the Oncomine Dx Target Test.
The FDA’s approval of Thermo Fisher’s Oncomine Dx Target Test for use with HERNEXEOS represents a critical convergence of scientific innovation, diagnostic precision, and therapeutic advancement. For the subset of NSCLC patients with HER2 (ERBB2) TKD activating mutations, this development offers a long-awaited targeted treatment option backed by a validated, widely available diagnostic tool.
By integrating advanced NGS-based testing with novel targeted therapies, the oncology field continues to move toward a future where every patient’s treatment plan is guided by the molecular fingerprint of their cancer—a shift that promises to improve outcomes, reduce unnecessary treatments, and bring hope to patient populations once considered untreatable.
For further details on Thermo Fisher’s Oncomine Dx Target Test and its role in precision oncology, visit thermofisher.com/cdx.
