Next-generation sequencing (NGS) has evolved from a research tool into clinical mainstay that is transforming precision oncology by enabling clinicians to match patients with therapies tailored to the molecular profile of their tumors. For pharmaceutical innovators, it provides a foundation for precision drug development. For patients, it represents faster, more targeted treatment options and the potential for improved outcomes. Yet, while science continues to advance, practical barriers—long turnaround times, complex workflows, and limited access to testing—have slowed the realization of precision medicine for all patients.
A decade in the making
For more than a decade, Thermo Fisher Scientific has helped shaped the role of NGS in oncology. Since the first NGS-based CDx agreement in 2015, the company has worked alongside global pharmaceutical partners, clinicians, and regulatory agencies to develop scalable testing solutions that help expand access to precision medicine for more patients.
A pivotal milestone came in 2017 with the U.S. Food and Drug Administration (FDA) approval of the Ion Torrent™ Oncomine™ Dx Target Test* as the first distributable NGS-based CDx [1]. It has since expanded to support numerous therapies and biomarkers, achieving regulatory approvals across 20 countries and reimbursement in 19 [2]. In Japan alone, over 120,000 patients have been tested using the Oncomine Dx Target Test, demonstrating how local in-country CDx solutions can drive access to targeted treatments.
This decade-long journey built more than a portfolio—it established the regulatory, scientific, and operational foundation needed to unlock the next phase of precision oncology testing.
The next era: rapid and decentralized CDx with the Oncomine Dx Express Test
In July 2025, the company marked a new chapter in its precision oncology journey with the FDA approval of the Ion Torrent™ Oncomine™ Dx Express Test** for CDx and tumor profiling, ushering in a new era of rapid, automated, and decentralized NGS CDx testing.
Built on the Ion Torrent™ Genexus™ Dx System, the test enables CDx and tumor profiling testing in as little as 24 hours, with as little as 20 minutes of hands-on time. This end-to-end automation converts what once was a multi-day, highly specialized process into a fast, streamlined workflow, that can be performed in local hospitals or community labs.
With results available as soon as the next day, the Oncomine Dx Express Test helps oncologists make timely, biomarker-driven decisions from the start. This rapid turnaround coupled with decentralized deployment represents a pivotal step towards making insights available to more patients, regardless of where they receive care. For pharmaceutical companies, it can mean a more seamless path to commercial CDx and therapy availability.
The tests approval in the U.S. includes both companion diagnostic and tumor profiling indications, covering a comprehensive panel of biomarkers across multiple tumor types. This enables clinical labs to identify patients eligible for approved therapies and provide physicians with biomarker profiles to be used alongside professional guidelines to inform treatment decisions.
Why it matters: expanding access and accelerating adoption
Despite its transformative potential, traditional NGS technologies often face a key limitation: time. For many patients, NGS results can take weeks to return–forcing oncologists to initiate treatment before genomic data is available. However, delays in obtaining results can hinder clinicians’ ability to make informed decisions, potentially causing patients to miss out on targeted therapies, which can impact treatment efficacy and patient outcomes.
The Oncomine Dx Express Test addresses this challenge directly. By enabling in-country and in-hospital testing, NGS results are closer to patients and help to reduce the lengthy delays of sending out testing. In addition to improving time, the Oncomine Dx Express Test addresses some of the most persistent operational barriers that have limited widespread NGS adoption. Its validated workflow streamlines the verification process, reducing the burden for labs. Automation and minimal hands-on time help labs operate more efficiently without requiring specialized expertise. Together, these factors open the door for a broader range of clinical laboratories.
For pharmaceutical companies, decentralized CDx capabilities creates a practical advantage during and after launch. Localized testing facilitates in-country access, supporting joint launch strategies, and enabling therapies to reach more patients.
The right partner for the next decade of CDx innovation
2025 represents a culmination of Thermo Fisher’s proven experience in regulatory navigation, pharma collaborations, and global commercialization. With a decade of CDx co-development experience, the company brings extensive experience to pharma partners looking to accelerate the path from biomarker discovery to patient impact.
As precision medicine becomes more decentralized and data-driven, choosing the right CDx partner will be key to ensuring therapies reach the patients who can benefit most. Thermo Fisher’s end-to-end ecosystem—from clinical sequencing to proteomics and clinical services—positions it as a collaborator in that mission.
In oncology, every day matters. By combining speed, scalability, and scientific rigor, Thermo Fisher is enabling pharma innovators to bring precision medicine to patients globally.
- U.S. Food and Drug Administration. List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). Accessed October 13, 2025. https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools
- Thermo Fisher Scientific, Companion Diagnostics. Accessed October 13, 2025. https://www.thermofisher.com/us/en/home/clinical/diagnostic-development/companion-diagnostics.html.
*Oncomine Dx Target Test is For In Vitro Diagnostic Use.
**Oncomine Dx Express Test is For In Vitro Diagnostic Use. Intended use varies by region. Refer to the Instructions for Use.
*Oncomine Dx Target Test Abbreviated Intended Use: The Oncomine™ Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high throughput, parallel-sequencing technology to detect single nucleotide variants (SNVs), deletions, and insertions in 23 genes from DNA and fusions in ROS1 and RET from RNA isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer, IDH1 SNVs from FFPE tumor tissue samples from patients with cholangiocarcinoma, BRAF V600E mutations from FFPE tumor tissue samples from patients with anaplastic thyroid cancer, IDH1 and IDH2 SNVs from FFPE tumor tissue samples from patients with astrocytoma or oligodendroglioma, RET SNVs, multi-nucleotide variants (MNVs), and deletions from DNA isolated from FFPE tumor tissue samples from patients with medullary thyroid cancer, and RET fusions from RNA isolated from FFPE tumor tissue samples from patients with thyroid cancer using the Ion PGM™ Dx System.
**Oncomine Dx Express Test (US) Abbreviated Intended Use: The Oncomine Dx™ Express Test is a qualitative in vitro diagnostic test. The Oncomine Express Test is indicated as a companion diagnostic (CDx) to identify non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations for treatment with ZEGFROVY™ (sunvozertinib) in accordance with the approved therapeutic product labeling. The Oncomine Dx Express Test detects biomarkers recommended by professional guidelines for multiple solid tumors, including substitutions, insertions, and deletions in 42 genes, copy number variants in 10 genes, and fusions or splice variants in 18 genes.