Expanding Precision Medicine Through Rapid, Distributed NGS Companion Diagnostics

Overview

Next-generation sequencing (NGS) has become an important part of precision oncology, but access to NGS-based testing remains uneven across laboratories and geographies.

In a GenomeWeb interview, Jane Li, who leads pharma CDx partnerships at Thermo Fisher Scientific, discusses how rapid turnaround times, automation, and distributed testing models could expand the reach of NGS companion diagnostics and support pharmaceutical companies bringing biomarker-driven therapies to patients globally.

Expanding NGS-based testing globally

NGS-based testing has traditionally been concentrated in major academic centers and centralized laboratories with specialized personnel and infrastructure.

For biopharma, limited testing capacity outside of these centers can affect biomarker identification, patient access, and global commercialization of targeted therapies. Li describes how a more distributed approach in which automated NGS systems can be implemented across a broader range of laboratories could bring testing closer to patients and help expand access to biomarker testing.

Making NGS fast enough for treatment decisions

Broad molecular profiling can identify multiple biomarkers from a single sample, but turnaround time remains an important consideration.

When NGS results take weeks, clinicians may need to make treatment decisions before biomarker information is available. Rapid NGS has the potential to narrow that gap and help eligible patients receive targeted therapies sooner.

Moving from technology to clinical solutions

The interview also highlights a shift in how diagnostics companies approach NGS.

A technology-focused model emphasizes greater information and higher throughput. In a clinical setting, however, solutions must also reflect the operational realities of routine laboratories. These laboratories may not have highly specialized personnel, making automated end-to-end workflows important for broader implementation.

Automating NGS from sample to report

For use in community settings, the NGS workflow needs to be automated from sample to report, with less dependence on specialized knowledge, interpretation, or subjective judgment.

The goal described in the interview is for NGS to become more like immunohistochemistry, or IHC: automated, easy to use, and widely available so testing can be performed locally, and patients can move to treatment more quickly.

Building a distributed CDx model

Centralized commercial laboratories remain an important component of companion diagnostic testing, particularly in the United States. However, pharmaceutical launches increasingly span countries with different healthcare systems, laboratory networks, regulatory pathways, and reimbursement models.

A distributed CDx strategy can complement centralized testing by enabling validated companion diagnostic testing in local laboratories.

This model can help pharmaceutical companies build testing capacity closer to patients while supporting consistent deployment of a companion diagnostic across multiple regions.

Advancing rapid NGS CDx

The interview highlighted that Thermo Fisher Scientific received FDA approval in July 2025 for its latest rapid NGS CDx platform.

The platform is described as automated end to end, suitable for laboratories without deep NGS expertise, and capable of delivering results in as little as 24 hours.

Thermo Fisher Scientific is also working to expand global access to the platform and supporting pharmaceutical partners in bringing additional therapies onto it. In the second half of 2025, the platform was submitted to the PMDA in Japan and to an IVDR notified body in Europe.

More than 30 CDx programs were in the pipeline across different solid-tumor indications and sample types, including tissue, plasma, and urine. The company also stated that it planned more than 35 regulatory submissions across different regions over the following two years.

Expanding NGS CDx into hematology

One trend highlighted for the future is the expansion of NGS companion diagnostics into hematological cancers.

Most NGS CDx progress over the previous decade focused on solid tumors, but similar momentum is now developing in hematology.

In acute myeloid leukemia, increasing biomarker complexity is contributing to a shift from PCR-based single-gene testing toward NGS CDx.

Treatment decisions for AML patients often need to be made within 72 hours, creating a need for rapid myeloid NGS CDx solutions.

Multi-omics as the next CDx frontier

The second future trend identified in the interview is multi-omics.

As therapies and testing expand, tissue remains limited. Integrating molecular and protein biomarkers on a single platform can help generate more clinical information from one sample. The interview identifies NGS as being positioned to support this approach.

The future of NGS for companion diagnostics

The interview points to a clear direction for NGS companion diagnostics: broader access, faster turnaround times, end-to-end automation, distributed testing, expansion into hematological cancers, and multi-omics. The overall objective is to make NGS testing faster and more accessible across a wider range of clinical laboratory settings.