BioPharma APAC spoke with Jane Li, Senior Director, Pharma CDx and CRO Partnership at Thermo Fisher Scientific, about the development of the Oncomine™ Dx Express Test. She explains how this next-generation diagnostic platform is designed to close testing gaps in breast and solid tumours, accelerate precision oncology with a 24-hour turnaround, and enable broader adoption of in-country CDx solutions across Japan and the wider Asia-Pacific region.

What prompted Thermo Fisher Scientific to develop the Oncomine™ Dx Express Test as a follow-up to the already approved Multi-CDx platform, and how does it address current gaps in breast and solid tumour diagnostics in Asia, particularly Japan?

Cancer is the leading cause of death in Japan, with an estimated 1,019,000 new cancer cases and 380,400 cancer deaths in 2022. Despite the high disease burden, patients have lacked in-country companion diagnostic (CDx) solutions for important biomarkers like PIK3CA/AKT1/PTEN in breast cancer and NTRK fusions in solid tumors. This left a gap between approved therapies and the ability to identify eligible patients in commercial testing. 

The Oncomine™ Dx Express Test is aimed at helping address this unmet clinical need by providing for in-country CDx testing for timely treatment decisions. For patients in Japan with these specific forms of breast cancer and Pan Cancer NTRK fusions, once approved, the Oncomine™ Dx Express Test, which runs on the Genexus Dx System, will enable rapid, automated next-generation sequencing (NGS) testing with results delivered in as little as 24 hours. This will provide oncologists and pathologists with a practical solution to accelerate results reporting and treatment matching. By automating complex workflows and enabling in-house genomic testing, the test will help  close the  gaps in Japan, particularly in settings where access to centralized labs remains limited. 

With a 24-hour turnaround for results, what clinical impact do you anticipate this will have on oncologists’ ability to make timely, personalised treatment decisions?

Oncology patients — particularly those with aggressive or late-stage cancers — cannot afford delays in care, but the traditional molecular testing testing and reporting process often takes days or weeks to return results. Further, studies show that nearly 50% of eligible patients miss out on targeted therapies due to testing and reporting delays, access limitations, or lab bottlenecks. 

The Oncomine Dx Express Test directly addresses this by dramatically reducing overall turnaround time. This speed gives oncologists and pathologists the ability to make informed treatment decisions quickly and in many cases 24-48 hours, helping oncologists connect patients to the therapy best suited for their tumor profile in a timelier manner. By accelerating access to precision oncology, the Oncomine Dx Express Test can make a difference in aligning patients with the most effective therapies when time is most limited.

Can you elaborate on the technical innovations that differentiate the Oncomine™ Dx Express Test from other NGS-based diagnostic platforms currently on the market?

Ultimately, NGS helps make cancer diagnosis and treatment plans more personalized and accurate by matching each patient with the best possible treatment for their specific type of tumor. It is the connector between the most appropriate therapy and a specific patient. 

Traditional NGS platforms require specialized expertise, multiple manual steps, and significant lab resources, which can delay results and limit adoption in community hospitals. The Oncomine™ Dx Express Test stands out thanks to the automated Ion Torrent Genexus Dx System, which streamlines the entire NGS workflow — from nucleic acid extraction and library prep to sequencing and reporting. This automation enables the system to deliver results quickly and broadens the usability of NGS across more labs and care settings, including those that previously lacked the capacity to perform complex molecular testing.  

In short, the innovation lies in combining automation, scalability, and accuracy into a single system that allows labs of varying capacity to perform advanced molecular testing and bring precision oncology closer to the patient.

How does Thermo Fisher envision working with Japan’s regulatory and clinical stakeholders to integrate this system into national cancer care protocols post-approval?

One of the biggest challenges in Japan (and globally) is that many regional and community hospitals lack the capacity to perform in-house NGS testing, which forces reliance on centralized labs that can take weeks to return results. By working with regulators, clinicians, and healthcare systems, Thermo Fisher aims to integrate this platform into national cancer care protocols so patients everywhere — not just those treated in large academic centers — can benefit from faster, more accessible precision oncology. Building on our long history of collaboration with Japan regulatory agencies, medical societies and pharma partners since 2017 on our previous multi-CDx solution, we plan to support adoption of our new CDx solution across diverse care settings, advancing patient access to precision oncology throughout Japan and beyond. 

Looking beyond Japan, what are the expansion plans for this system across the broader APAC region, especially in emerging oncology markets where diagnostic access remains limited?

Thermo Fisher's goal is to ensure NGS is readily available to patients who may benefit from this testing around the world, including other APAC countries. The Oncomine Dx Express Assay on Genexus Dx System is already registered in Singapore, Thailand, Malaysia and in registration process in a number of additional APAC countries that recognize the CE-IVD label, and is particularly beneficial in markets where access to NGS is limited by either resources or demand. By delivering automated, rapid, high-precision diagnostics, the system has the potential to bring personalized oncology care to more patients, reduce testing bottlenecks, and support timely initiation of targeted therapies.

From a global perspective, how is Thermo Fisher adapting its CDx strategy to stay ahead of evolving therapeutic landscapes and biomarker discovery trends in oncology?

The pace of oncology innovation is accelerating quickly, with new biomarkers and therapies being introduced at unprecedented speed. This creates pressure to ensure CDx platforms can keep up with evolving therapeutic landscapes. Thermo Fisher is continuously investing in innovations that combine speed, scalability, and accuracy, ensuring its CDx platforms keep pace with evolving therapies and emerging biomarkers. 

We’re also looking at emerging new indications and sample types, partnering with leading pharmaceutical companies to ensure that novel therapies in their pipeline will be well-supported with diagnostic testing by the time they reach the market.

(arcilla.fran@biopharmaapac.com)