Bringing Pathology into the Digital Age – An interview with Michael Bonham, MD, PhD, Chief Medical Officer of Proscia – Part 2 of 2
Pathologists have used the same technology to make diagnoses for the past one hundred and fifty years - tissue sections mounted on glass slides, examined under the light microscope. Will pathology be able to go fully digital and enter the twenty-first century? We’re joined by Michael Bonham MD, PhD, Chief Medical Officer of Proscia, a company looking to perfect cancer diagnosis through intelligent software.
… continued from part 1
Michael Bonham, MD, PhD: Further, there are countries in this world where there are practically no pathologists. I was recently talking to someone from a country in Southeast Asia, who said they had only four pathologists in their entire country. I said, “Four? I’ve got four pathologists just down the hall from me.” You really have to put it into perspective, just how large this global problem is.
Joseph Anderson, MD: This does sound like a large challenge. Speaking of inefficiencies in staffing, there was a wave of consolidation in pathology in the early 2000’s, with large players such as Quest Diagnostics, Ameripath, and even, in some cases, hospital systems acquiring pathology practices. The administrators discovered a new tool, called “FedEx,” to transport glass slides and were able to squeeze out a lot of the inefficiencies in the practices. Do you think we're going to be able to squeeze out even more inefficiencies using digital pathology without the need to ship glass slides around?
MB: Well, I’ve got to say, that I have received FedEx packages myself - gigantic FedEx packages that probably cost fifty hundred dollars to send - with one slide inside. It's almost comical. In terms of the efficiency gains, there's been some studies to show that moving to digital does allow for some gains. The problem is that the gains that we're seeing are not enough to justify the infrastructure cost, the IT costs and changing people's ways of doing things. They're not enough to move the needle. That's really why we're trying to offer something entirely new.
JA: So just what is the promise of digital pathology?
MB: You have to think about what the promise of any transition from an analog process to a digital process is. Think about how we used to listen to records, and we used to use typewriters. Now, we would never consider going back to those ways. Digital technology has really changed everything that we do in our in our lives right now. Yet in medicine, that transition has been much more difficult. When it comes to getting the diagnosis for a disease, we still live in an analog world.
The promise is, that once you take that glass slide and it is scanned, that slide is now virtualized. It is a piece of data that can be parsed in any way; it can be copied; it can be sent anywhere; it can be moved; it can be analyzed. Exponential opportunities are created that were not possible on a glass slide. The information that is locked in this tissue on the glass is very rich. Once that slide is scanned, it creates very large image files - much bigger than a CT scan - ten times bigger. There's so much data sitting there that we're not able to use because it is beyond what any one human being can interpret - thousands of cells, three dimensional structures organized to make normal and abnormal shapes and structures and colors. It's just incredible the amount of information that is there. Digital pathology brings that to light.
JA: I think we're really on the verge of something big here. There's so much rich information there that people may not appreciate. I don't think it's much of an exaggeration to say that this could be potentially comparable to the unlocking of the human genome - the amount of data and information we're going to be able to uncover and to utilize.
MB: I totally agree. I make an analogy to working in a laboratory using agarose gels. We would run experiments on DNA to get the sequence. You'd be lucky to get a sequence of a hundred base pairs. That was thirty years ago. Look around today with next generation sequencing and the ability to sequence the whole genome in several hours and for less than a thousand dollars. This is all because of a transformation to digital. So really, the possibilities are incredibly exciting when you put it in that perspective
When you think about what happened with genomics in going from manual sequencing to next generation sequencing, my hope is that we're talking about a change that is on the same magnitude in digital pathology. I would also say that beyond the new discoveries that will take place, there is a giant change that will take place in the way pathology is practiced. Pathologists will no longer be physically constrained. Now they lead a largely siloed existence, chained to the microscope. In a way, we have to exist wherever that microscope is, and where that lab is.
Imagine a world that is somewhat decentralized, and it is digital. We have instantaneous sharing of information, remote viewing, quantifying details that are just way beyond what any human being is capable of. That is what excites me about the future of pathology. But ultimately, it all comes down to, “what is the benefit?” In my mind it is going to be: 1) increased accuracy, 2) reduced subjectivity and 3) better patient outcomes. And digital pathology is really the only solution that is going to meet the demand problem that we discussed earlier regarding the number of pathologists available versus the need for their expertise.
JA: Pathology is often compared with its counterpart specialty, radiology, which has been fully digitized for some time now. Why is it taking so long, and will pathology finally be ready to make the leap?
MB: This is a complicated subject. There are many reasons for it. It is remarkable to me that digital technology is still at a very low adoption rate in the United States - probably less than five percent of labs routinely use digital pathology in clinical practice. As you touched on earlier, the microscope works well for what pathologists have been asked to do. But, as we’re finding out, the microscope is maxed out. The complexity of treatments and information required for these treatments goes up every year. The amount of information required for an individual case is exponentially increasing. It is becoming beyond what any one person can provide using a microscope, and it's only going to increase.
The microscope has gotten us far. But now, we need to think of something different. Why is this not happening? First, medicine, in general, is resistant to change. There are very serious consequences for error. You have to do a lot of clinical studies and validation studies to make sure anything that you're changing is not going to do harm, but rather it’s going to benefit patients. We need good evidence.
Second, the images generated are quite large. They require a huge amount of processing power, storage capacity and infrastructure. This has not been routinely available. It requires a large up-front investment for labs who want to work digitally. There are significant overhead costs to make this transition.
Third, you also have a transition in how you practice. If you’ve been using a microscope for twenty or thirty years, you can't just flip on a monitor and go digital. This is not how the human brain works. There’s a mind-body connection and muscle memory that you have from doing the same thing for thirty years. You can't just say that it's going to be exactly the same user experience. It will take some time to adjust.
Fourth, we also need to show very clearly that there's value from an outcomes basis to going digital. You can make the cost argument. But once you have a value argument for outcomes, that really changes the equation. I really hope that we begin to see outcomes-based evidence showing that labs are digital have better patient outcomes. That’s where we can really start to move the needle.
And Finally, we do have regulatory hurdles - particularly in the United States. The FDA, almost eight years ago, declared a slide scanner to be a medical device. The microscope, though, with basically the same use case, is essentially unregulated. It’s very hard to have the regulatory evidence to support going digital. We do, though, now have approvals for the Philips system and the Leica system. I expect that we'll see more in the coming years. That's a big step that will really help drive this transition.
JA: I think we have a lot to look forward to, and it feels like we're just scratching the surface. Mike, how can people learn more about Proscia and digital pathology?
MB: We have a website, Proscia.com. That is probably the best destination. You can also follow us on Twitter and Linkedin. We give a number of webinars every year. We come to all the major conferences. We try to be as available as possible.