CAP25: FDA Approvals That Are Reshaping Pathology

By Inga Rose, CEO, Reference Medicine

Every year, CAP brings together the pathology community in one place. It’s where we trade slides and stories, debate standards, and catch up on the latest in science and practice. But CAP25 in Orlando had a different kind of electricity running through it this year. And no, not just because Mickey Mouse was a 10-minute Uber ride away.

It wasn’t just the lively poster hall or the clusters of pathologists examining digital screens, verbally challenging the newest AI Pathology algorithms - it was the steady drumbeat of FDA approvals being announced or highlighted right in the middle of the meeting. The sense that we weren’t just talking about the future of diagnostics, but actually watching it arrive in real time.

Biocartis Raises the Bar with Tissue-Informed MSI Testing

The true headline of CAP25 was Biocartis’s FDA Premarket Approval (PMA) for the Idylla™ CDx MSI Test.

For colorectal cancer patients, MSI status is one of the most consequential biomarkers—it can dictate whether immunotherapy is an option and which regimen is chosen. Until now, MSI testing has often meant long turnaround times, complex workflows, and lab teams juggling batch-based assays that don’t fit seamlessly into day-to-day practice.

The Idylla system flips that script. It’s cartridge-based, fully automated, and sample-to-result in literally hours. No batching, no extra complexity. This isn’t just incremental progress; it’s transformative for accessibility.

What really struck me is that this isn’t just a technical win for pathology labs, it’s a clinical win. MSI-H patients can be identified quickly and accurately, opening the door to treatments like nivolumab (Opdivo®) or the combination of nivolumab with ipilimumab (Yervoy®). In an era when time lost can mean treatment delayed, that’s a profound shift.

Roche’s MET CDx: A Landmark in Lung Cancer Diagnostics

While technically approved a few months before CAP25, Roche Tissue Diagnostics’ VENTANA MET (SP44) RxDx Assay was front and center at the meeting - and with good reason.

This is the first FDA-approved IHC companion diagnostic to detect c-MET protein overexpression in non-squamous NSCLC. It’s paired with AbbVie’s newly approved targeted therapy, Emrelis™ (telisotuzumab vedotin-tllv).

Why does this matter? Because IHC is one of the most universal, established tools in pathology. To see it evolve into a precise companion diagnostic that literally unlocks access to a targeted therapy is a milestone. It demonstrates that the tried-and-true methods we know - when optimized, validated, and paired with the right therapy - can become precision medicine powerhouses.

At CAP25, Roche’s team made sure no one missed the significance. And walking through their booth, it was clear: this is not just a test, it’s a new model for how diagnostics and therapeutics move forward in lockstep.

Digital Pathology and AI: From Future Promise to FDA Reality

CAP25 also put a spotlight on how far digital pathology and AI have come in just a few years. The buzz around PathAI’s FDA clearance for AISight Dx IMS was undeniable.

This 510(k) clearance validates the use of digital pathology platforms for primary diagnosis. That means whole slide imaging and AI-augmented workflows are no longer experiments at the margins - they’re entering the mainstream of clinical practice and can be leveraged from anywhere in the world. Absolutely mind-blowing.

Digital pathology isn’t just about faster reads or remote access. It’s about building the infrastructure for biomarker discovery, AI-powered triage, and global collaboration. And seeing regulatory approval catch up with what innovators have been pushing toward for years was one of those CAP moments that made the future feel very present.

Why This Matters for All of Us

These announcements aren’t just headlines for diagnostics companies. For those of us working every day in biospecimens, clinical validation, and translational research, they are proof points that the system is working.

• Specimen quality matters. You can’t get to FDA approval without tissue-informed validations, rigorously QC’d samples, and data integrity.
  Collaboration matters. None of these approvals happen in isolation - they require tight coordination between pharma, diagnostics, pathologists, and trusted specimen providers (hmm-hmmm, like Reference Medicine 😉).
• Access matters. Faster, more automated tests mean more patients, in more places, can actually benefit from the science.

We have the privilege of seeing and experiencing all of this firsthand. The matched sets, the deeply annotated tissue-plasma-buffy collections, the quality standards we insist on - all of it is designed to fuel exactly the kind of work that leads to regulatory breakthroughs like the ones highlighted at CAP25.

A Closing Reflection

Walking out of CAP25, I felt energized in a way that’s hard to capture. It wasn’t just that there were shiny new posters or crowded sessions, or that the food served was pretty exceptional. It was that the arc of progress felt visible.

From Biocartis’s leap forward in MSI testing, to Roche’s landmark MET companion diagnostic, to PathAI’s AI clearance, we’re witnessing an acceleration in how diagnostics move from the lab bench into patient care.

For a company like ours, rooted in the belief that high-quality specimens can change the course of cancer diagnostics, CAP25 was a reminder: our work matters. The partnerships matter. And the future we’re building together is arriving faster than ever.