'AI holds enormous promise to aid clinicians in making informed decisions among many different treatment pathways'

In July 2025, the FDA approved the Oncomine Dx Express Test, a next-generation sequencing (NGS) platform developed by Thermo Fisher Scientific. The firm is now seeking approval in Japan, where cancer is the leading cause of death, with over one million new cases diagnosed annually. Thermo Fisher Scientific has submitted a medical device manufacturing and marketing approval application to Japan's Ministry of Health, Labour and Welfare for the Oncomine Dx Express Test Multi-CDx System, which automates the entire diagnostic workflow and delivers results in as little as 24 hours. Designed for rapid, high-precision diagnostics in breast cancer and solid tumours, the system aims to personalise care and accelerate treatment decisions. Jane Li, Senior Director of Pharma CDx and CRO Partnerships, Clinical Sequencing, discusses how the new system advances on the earlier test, trends in pharma-diagnostic collaborations globally and in Asia, key challenges in scaling NGS adoption, and the role of automation and AI in shaping the future of personalised medicine. Edited excerpts:

- Ayesha Siddiqui

How does the Oncomine Dx Express Test Multi-CDx System improve on your earlier Oncomine Dx Target Test, and what impact could it have on cancer care in Asia?

The Oncomine Dx Express Test is our latest dual-use companion diagnostic (CDx) for both tissue and liquid biopsy samples, compared to the prior Oncomine Dx Target Test which supported only tissue samples. The Oncomine Dx Express Test July submission to Pharmaceuticals and Medical Devices Agency is for tissue, with a liquid biopsy submission planned for the future. Additionally, Oncomine Dx Express Test runs on the Genexus Dx system, our rapid automated next-generation sequencing (NGS) platform that can deliver results in as little as 24 hours. This speed enables more timely treatment decisions for patients. The automated Genexus system also makes it possible to implement NGS testing in smaller local hospitals without requiring prior expertise, bringing testing in-house today. The Oncomine Dx Express Test has the potential to expand NGS access and accelerate treatment decisions across Asia.

Cancer is the leading cause of death in Japan, with more than one million new cases diagnosed annually. By enabling local and regional hospitals to conduct advanced genomic testing themselves, the Express Test shifts testing from centralised to decentralised models. This could accelerate equitable access to targeted therapies across Asia's diverse healthcare systems, from major urban cancer centers to smaller community hospitals.

With results available in as little as 24 hours, how do you see rapid turnaround times changing treatment decisions in oncology?