Microscope to image—big lift but also a blueprint

Create PDF

Proscia’s David West on Concentriq AP-Dx Clearance and Beyond

April 2024—The Food and Drug Administration in February cleared Proscia’s Concentriq AP-Dx digital pathology software for the purpose of primary diagnosis. Shortly after, Proscia cofounder and CEO David West spoke with CAP TODAY publisher Bob McGonnagle about achieving new efficiencies, elevating pathology, the heterogeneous nature of the pathology community, and being able to learn from digital pathology’s early adopters. “Laboratories and pathologists going digital don’t have to be first anymore,” West said.

David, tell us about the exciting news at Proscia.
David West, cofounder and CEO, Proscia: We announced on February 12 the 510(k) clearance of Concentriq AP-Dx, our diagnostic software solution for viewing, interpreting, sharing, and managing whole slide images. It’s available for primary diagnostic use in the United States, at an important time for the market and for pathology in general.

Give us a sense of the timeline and background on Proscia and yourself.
David West: I’m a software guy at heart, and I fell in love with pathology when I was at Johns Hopkins about 10 years ago, working with scientists to build computer vision and machine learning algorithms that would predict prostate cancer outcomes from biopsies. I was fascinated by the idea that we can use computers to understand cancer in a deeper way, different from the standard of care. It inspired me to start the company.

In 2016 it became my full-time job. We raised investor capital, and to date we’ve raised about $80 million. In our early days we were selling to life sciences with a product that supported research workflows from early-stage discovery through clinical trials. The holy grail is to offer a solution for diagnostic use, and our 510(k) enables us to do this in the U.S. We were the first to achieve CE-IVDR certification in the European Union, and we have a solution that is Health Canada licensed and cleared for primary diagnosis in the United Kingdom, among other countries.

West

One of the biggest boons for digital pathology was the shortage of pathologists in the United States, which we hadn’t seen until about two years ago. The shortage was already rampant in Europe, where some of the earliest adoption of digital pathology happened. Tell us how the U.S. market has evolved and how it has helped your company.
David West: The growing adoption we’ve seen abroad was a precursor to what has happened here in the U.S. It started in places like the Nordic countries, where there are very few pathologists to serve patients. And as the pathologist workforce shortage has rolled across different geographies, we’ve seen digital pathology adoption follow. These have been correlated variables. This makes sense because the workforce shortage, perhaps accelerated by COVID, has put so much pressure on laboratories that they need to go digital to unlock new efficiencies, attract talent, and prepare themselves for a technology-driven future where diagnostic complexity is increasing, especially as new precision therapies come to market. It’s making the pathologist’s job harder but also more impactful. They need these technologies to keep up.

The surge in digital pathology adoption, globally and in the U.S., has been accompanied by a growing base of evidence on the benefits of digital pathology, further accelerating the momentum. We have been fortunate to sign on many new customers as a result.

Now that the market has matured, we’ve had multiple approvals from the FDA for primary diagnosis and seen the Digital Pathology Association lift off like a rocket. We also have the tailwind of AI, for better or worse. It seems to many people that we’re not going to go back. For example, if three years from now we have a surplus of pathologists, will digital pathology instruments and operations be put in a closet and gather dust? Can you speak to that future over the short term?
David West: At Proscia we use the well-known concept of one-way and two-way doors around decision-making. Some decisions are one way; with others you can go back because they’re reversible decisions. Going digital for a laboratory is a one-way door. They go through the process, fall in love with it, and transform their operation around it. But it’s a hard door to go through; it’s not trivial. Adopting the technology requires investment and a rethinking of the laboratory operation. It’s not just buying scanners or getting pathologists and laboratory staff comfortable with the software. It’s about sometimes changing their processes around a new way of practicing pathology. So far it’s been very successful. We get data from analysts who poll laboratories on whether their implementation was successful. The vast majority of laboratories and pathologists say they’re seeing a lot of benefit.

A more measured take is that the early wave of adopters of this technology hit stumbling blocks. There were challenges in going digital—maybe they got locked into the wrong scanner, found there were image quality issues, or needed more functionality in their software. The good news is the labs that are going digital today have much more mature technology available and a blueprint to leverage. They can learn from the experiences of the early adopters.