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.
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.
Pathology is becoming ever more complex. There’s a large distinction in the country between community-based pathologists, who are squeezed for time and capital, and academic pathology, where there is considerable subspecialization. There are fewer general surgeons, and if there aren’t general surgeons, you won’t have many general pathologists. Do you agree?
David West: I do. The subspecialization trend is inevitable for a few reasons. First, it’s often better for patients since it means that a pathologist with expertise specific to their case is providing a diagnosis. The growing complexity of pathology is also contributing to this trend. We’re seeing more and more specialty tests and companion diagnostics enter the clinic, and these require someone with specialized expertise to interpret them and realize their full value. In parallel, digital pathology makes it easy for laboratories to tap into subspecialist expertise since it no longer matters where a pathologist is located. This is especially impactful when you consider the intensifying pathologist shortage.
You have to know the kind of pathologist you’re working with. There’s no uniformity, even at large academic institutions, among all the pathologists, is there?
David West: Definitely not. There’s a lot of texture in this community. We’ve seen this with the adoption of digital pathology—there are people who embrace it right away and others who are less sure and have to get comfortable with the technology. We need to make sure as a community that we’ve calibrated the products we build to the heterogeneous community that is pathology. Part of our challenge as advocates and builders of this technology is how we help everyone get the best out of it.
Many systems, hospitals, and laboratories are doing a vast amount of digitization of their slides without necessarily digging into the richness of what they’ve digitized. Do you see that in the marketplace?
David West: This has been part of our mission at Proscia. In the early days of digital pathology, it was thought of as a replacement for the microscope. You see this in the way agencies are regulating the technology. But what got me most excited about digital pathology was the opportunity to take a discipline that is producing incredible amounts of information, knowledge, and data and help us, as a health care and life sciences medical community, get the most out of it.
In many ways the gigabyte-size images that are generated have been thought of as both a cost and an IT burden. And they are. We’ve tried to assume some of that burden to make it easier for laboratories to focus on what they do well. At the same time, these images represent a new source of real-world data that can power early-stage research in academic settings or in biopharma and help us discover and develop novel therapies and diagnostics. There are amazing translational use cases as well as impacts on clinical trials. There is an opportunity to leverage the tissue and image data to advance precision medicine, ensuring patients get the right treatment and are enrolled in the right clinical trial, and we are working to help our customers capitalize on this.
The field of computational pathology is bringing in very smart people who are rounding out pathology departments with expertise in data handling, et cetera, and initiatives have been announced recently at the University of Pittsburgh and Indiana University. It’s a brilliant development and may lead to pathology leading diagnosis and treatment.
David West: I agree. Pathology images are the most information-dense snapshots of disease, and an incredibly rich information paradigm is now coming out of the laboratory. When you have computational tools, you can leverage more of that information to make a diagnosis and determine the best course of treatment, rather than distill everything on the slide into a couple of dictated sentences on a PDF report. The days of blunt-force treatments are starting to be behind us as precision medicine advances, which is great for patients but puts more burden on pathologists—we’ve seen this with PD-L1 quantification algorithms. There’s an opportunity to equip pathologists with the right tools so they can play an even bigger role in care decision-making with oncologists, dermatologists, surgeons, gastroenterologists, whomever they’re working with. Computational applications like these elevate the role of the pathologist and enable pathologists to serve as informaticists. They might in the future be coordinating a portfolio or menu of computational and molecular algorithms that can be valuable to stakeholders in different parts of the care value chain.
Can you talk about the marriage of pathology and radiology? This idea has never died; it just goes away for a while. The last surge of interest in this was about combining pathology and radiology into something like a department of diagnostic medicine. Do you recall that?
David West: Yes. A big driver of digitization has not just been pathology departments but also stakeholders outside of pathology who are saying, You’re going digital; we can integrate this into our radiology informatics and we have a budget as part of a broader diagnostic imaging initiative. We are seeing that integration in soft ways within the hospital system and sometimes in more explicit ways. For example, some academic medical centers have structured joint radiology and pathology boards, called integrated diagnostics boards. It’s an interesting direction. Hopefully it gives pathology more of a seat at the table, more capital as well.
Is there anything more you’d like to add?
David West: This is just the beginning for digital pathology. We’re in the first or second generation of this technology. While we’re also still in the early phases of market adoption, laboratories and pathologists going digital don’t have to be first anymore. Shifting from microscope to image can be a big lift, but there are great people who have gone before you who can offer a blueprint for your journey. I also want to reiterate the impact that digital pathology and AI are making for pathologists, including elevating their role in the precision medicine paradigm. It’s time pathologists get the technology and recognition they deserve.