In an interaction with MedTech Spectrum, Jane Li, Senior Director of Pharma CDx and CRO Partnerships at Thermo Fisher Scientific, discussed the recent FDA approval of the Oncomine Dx Express Test. Designed as a next-generation sequencing (NGS)-based companion diagnostic, the test offers rapid and accurate detection of clinically significant mutations, including EGFR exon 20 insertions. This enables clinicians to identify non-small cell lung cancer (NSCLC) patients who may benefit from targeted therapies such as ZEGFROVY. Li noted that the approval marks a key advancement in making precision oncology more accessible, aligning with Thermo Fisher’s ongoing commitment to deliver fast, clinically actionable insights that personalise care and improve outcomes for cancer patients across diverse treatment settings.

How does the FDA approval of the Oncomine Dx Express Test as a companion diagnostic for ZEGFROVY take care for NSCLC patients with EGFR exon 20 insertion mutations?

The FDA approval of the Oncomine Dx Express Test advances patient care by enabling rapid and decentralised genomic testing to identify NSCLC patients with EGFR exon 20 insertion mutations who may benefit from sunvozertinib. Patients in this subgroup have historically had limited treatment options and complex diagnostic pathways that often required sending samples to large laboratories, resulting in long turnaround times.

The Oncomine Dx Express Test delivers results on the Ion Torrent Genexus™ Dx Integrated Sequencer in as little as 24 hours. This allows clinicians to make earlier, more informed treatment decisions, helping reduce delays and match patients to targeted therapy sooner and closer to home.

What were the key clinical and technical milestones that contributed to the test’s FDA approval, and how do they reflect Thermo Fisher’s broader strategy in precision oncology?

Key milestones included the clinical validation of the Oncomine Dx Express Test to detect EGFR exon 20 insertion mutations in patients enrolled in Dizal Pharma’s sunvozertinib clinical trial, demonstrating concordance with the clinical trial assay and overall response rate with sunvozertinib.

On the technical side, the automation of the NGS workflow on the Genexus Dx System supports consistent performance from nucleic acid extraction to reporting. This approach makes advanced genomic testing feasible in settings without prior NGS expertise.

These milestones align with Thermo Fisher’s broader strategy to decentralise and accelerate NGS testing by making precision oncology tools accessible in real-world clinical settings. This approval also adds to Thermo Fisher’s history of working with pharma partners to bring innovative new therapies to market through its companion diagnostics portfolio.

How does the decentralised deployment of the Ion Torrent Genexus Dx Integrated Sequencer improve access to timely genomic testing across various clinical settings?

Until now, advanced genomic testing required specialised infrastructure and trained personnel, which often meant sending samples off to large laboratories or academic hospitals and led to long turnaround times.

Approximately 85% of U.S. cancer patients receive care in community oncology settings rather than large academic centres, so making testing available locally is critical. Many patients live far from major academic hospitals — especially those in rural or underserved areas — where access to advanced diagnostics has traditionally been limited.

The Genexus Dx System simplifies the NGS process by automating the workflow, from specimen to report, making it feasible for use in smaller laboratories and community healthcare settings without prior NGS expertise. This decentralisation helps eliminate logistical barriers and allows more patients to benefit from local access to genomic testing with results available in as little as 24 hours. This faster turnaround means doctors get results sooner, so they can make informed decisions quickly, and patients don’t have to wait weeks for answers.

This technology also brings precision oncology closer to patients’ locations, reducing the need for travel and helping ensure that geographic location is not a barrier to timely, personalised care. By making precision oncology more accessible locally, we’re helping make it more equitable and practical for more patients.

What role did your collaboration with Dizal play in the development and validation of this companion diagnostic, and how do you envision future pharma partnerships shaping your NGS portfolio?

Companion diagnostics is a joint development process with a pharma partner parallel to the drug development process. It involves a large number of studies, including feasibility, analytical validation, and clinical validation, leading to regulatory submission, review and approval. In this case, we have closely collaborated with Dizal Pharma over the past five years to achieve contemporaneous submission and approval of sunvozertinib and the Oncomine Dx Express Test from the FDA.

This is the first companion diagnostic approval on the Oncomine Dx Express Test. We are actively working with pharma partners to bring more companion diagnostics onto the system for new therapies across solid tumour indications in the future.

Looking ahead, how will Thermo Fisher ensure widespread adoption and education around the Oncomine Dx Express Test to support clinicians, especially in community and smaller healthcare systems?

Within the laboratory, the Oncomine Dx Express Test requires only a verification step rather than a full validation, and the automated workflow with built-in informatics that generates an FDA-approved report reduces the need for extensive NGS experience. This lowers the barriers for smaller hospitals and non-NGS pathology labs to implement advanced testing.

Thermo Fisher provides end-to-end support, including training, onboarding, and ongoing service through established field support teams.

These efforts help more hospitals and community labs offer precision oncology locally so that more patients can access timely, targeted treatments without having to travel long distances.

( chaitrali.gajendragadkar@mmactiv.com )
MedTech Spectrum
www.medtechspectrum.com