Molecular Pathology Will Lean Further into Liquid Biopsy and Proteomics in 2026

Luca Quagliata, PhD, BCMAS, COA, is vice president and global head of medical and scientific affairs at Thermo Fisher Scientific. Quagliata sat down with Today’s Clinical Lab at the Association for Molecular Pathology’s annual meeting in November. In this interview, he discusses why liquid biopsy is gaining momentum, the concept of faster test turnarounds for pathologists, and why proteomics will gain further attention in 2026. He also explains how Thermo Fisher’s product line fits into these areas.

For many years, liquid biopsy did not seem to have the full confidence of the clinical laboratory and molecular pathology field. Now, people are discussing it more seriously. What is the current state of liquid biopsy?

Luca Quagliata: Before I joined Thermo Fisher about seven years ago, I was lab director of the molecular pathology unit at the University Hospital of Basel in Switzerland. I signed off my first liquid biopsy case in 2016. It was for a woman with lung cancer who turned out to have a T790M resistance mutation for EGFR [epidermal growth factor receptor]. If you read my research papers from the time, I was one of the people saying liquid biopsy is going to change the way we practice molecular pathology in the future. I was wrong with the timing of my predictions, as these changes happened only very recently. 

Over the last decade, the uptake of liquid biopsy has been slower than expected, in part because our efforts have been heavily centered on pushing analytical sensitivity to its limits. The truth is that, from a clinical standpoint, you don't really care if there's something at “0.00 whatever” unless it has a clinically meaningful impact on patient care management. And this acceptance is only happening now that we're starting to demonstrate that liquid biopsy results can have a tangible, clinically meaningful benefit. 

From the Thermo Fisher perspective, we have invested a lot in liquid biopsy and now have a portfolio of solutions across both of our sequencing platforms. This includes assays on the Ion S5 family, which uses technology capable of achieving extremely low limits of detection [LOD], and the Genexus System, where our Oncomine Precision Assay panel can be used on liquid biopsy samples. We have seen a much stronger uptake in liquid biopsy interest in the last couple of years.

What questions do pathologists ask you these days? 

LQ: The biggest request that we have from pathology directors and molecular pathologists is to have solutions with the fastest possible turnaround times. Thermo Fisher is well positioned to fill these pressing needs. In September, we got FDA approval of our Oncomine Dx Express Test in the United States for tumor profiling. That test has a turnaround time from a laboratory standpoint of 24 hours. In collaboration with several groups across the US, we published a study in the Journal of Clinical Oncology last year demonstrating a critical point: Delaying the initiation of therapy for patients with non-small cell lung cancer is associated with significantly worse survival outcomes. 

The reality is that if a molecular test takes weeks to complete, patients may not receive the results until after therapy has already begun. Even if they later switch to a targeted treatment, they will never experience the same survival benefit they would have achieved had the appropriate therapy been started immediately, guided by rapid molecular profiling from the outset. This is why pathologists and clinicians increasingly recognize the importance of rapid next-generation sequencing. They need technologies that can deliver results quickly enough to support timely, evidence-based clinical decisions.

From a business perspective, if you know that rapid turnaround is important for customers, how does Thermo Fisher deal with keeping the instrument affordable and making sure it's sensitive? 

LQ: The most expensive part of testing is not the actual test; it's the personnel cost because someone has to perform the workflow. That's one reason why Thermo Fisher worked hard to generate an end-to-end, fully automatized solution—the Genexus System. Ours is a walk-away instrument: You place your sample, you click a few buttons, you walk away, and then you come back in 24 hours after everything is done, including the data analysis. You don't have people holding pipettes for hours and scrambling around an instrument, which is chopped into many different steps. 

Reagent costs represent another substantial component of laboratory budgets. Thermo Fisher has introduced cost-efficient models, including reagent rental programs, that enable labs to manage expenses more effectively than alternative testing approaches.

You also asked about sensitivity. With our legacy proprietary chemistry Ion Torrent system, we have been able to develop something that is extremely sensitive. We have not compromised quality for speed. Our aim has always been to deliver a test that is both rapid and reliable. The recent FDA approval serves as validation of that approach.

Where do you see molecular pathology heading in 2026, either in terms of innovations or business trends?

LQ: In the field of molecular pathology, comprehensive genomic profiling for selected tumor indications is attracting a lot of attention, and it will play a major role in 2026. That's why we launched the Oncomine Comprehensive Assay Plus. This is a 500-plus-gene assay that enables broad biomarker profiling, and that reflects where the field is heading. With this assay we're actually looking at complex biomarkers, such as microsatellite instability, homologous recombination deficiency, tumor mutational burden, and copy number variants all at once. Because this assay now also works on the Genexus System, it still has a 24-hour turnaround time. The combination of speed and comprehensive results positions it as a meaningful solution for 2026. 

Stepping back for a broader view, there’s a growing conversation about what lies beyond genomics. We are unlikely to discover another single, high-impact oncogenic driver like BRAF or KRAS. While there is certainly still meaningful value to be extracted from the genome, the next major frontier is proteomics. We’re now seeing a wave of large, exploratory studies in this space, signaling a significant shift in how the field will evolve. And that's one reason why Thermo Fisher decided to make a large investment by acquiring Olink, which has a multiplexed proteomic platform. 

If I allow myself a moment of wishful thinking, I would love to see a future where people are not just getting molecular profiles by DNA and RNA sequencing, but they are combining DNA–RNA power along with proteins. But as a matter of fact, the future needs of molecular testing will be shaped by the therapies coming out of the pharmaceutical pipeline. We’ve seen this play out before, from the surge of targeted therapies to the sweeping impact of immuno-oncology. Now, the next major wave is antibody-drug conjugates. And to steer these therapies effectively, we must move beyond DNA alone and truly understand the proteins that drive their response. It is no longer just about the mutations; it is about the target, and the target is a protein. So, we need to have solutions for proteomics that are better than traditional, basic immunohistochemistry. That's where Olink comes into the play.

So, if a clinical lab professional or pathologist has not looked at proteomics yet, 2026 might be the year to do so.

LQ: Yes, start reading up on proteomics. Many large academic institutions in United States are, in fact, starting to move into that direction. We have gone down to the lowest possible LOD in genomics, looking for this needle in the haystack. That’s fine, but we need to add something to increase the sensitivity of our tests. That something is basically another analyte. And that analyte will be a protein.