Computational pathology company Paige lands FDA clearance

To start, Paige will only be able to use its FullFocus viewer with the Philips Ultra Fast scanner

Paige, an computational pathology company that uses machine learning and software to help pathologists diagnose cancer, has already been seeing major growth during the COVID pandemic, thanks to an increased interest in digital health. Now the company is about to become even more ubiquitous thanks to a new clearance it just received from the Federal Drug Administration.  

On Tuesday, the company announced that it received a 510(k) clearance from the FDA for its FullFocusTM viewer, which will allow it to be used in the primary diagnosis of digital pathology slides. The FullFocus viewer, which operates within the Paige Platform, allows users, meaning researchers and pathologists, to view any digital image, regardless of the scanning platform used to generate the image.  

This FDA clearance only applies to FullFocus when it’s being used in conjunction with the Philips Ultra Fast scanner, but Paige already says it plans to add additional scanners in the future.         

Founded in 2017 by Dr. Thomas Fuchs and colleagues from Memorial Sloan Kettering Cancer Center, the name Paige is an acronym for "Pathology AI Guidance Engine."

Paige allows pathologists to accurately diagnose and treat cancer through the use of artificial intelligence by offering them the ability to take a picture of a slide and then have a computer identify the patterns in that tissue. The company has already done early access launches in the U.S., Europe and Brazil, and its viewer has already received a CE Mark in Europe, a certification mark that shows that it has conformed with health, safety, and environmental protection standards for products sold within the European Economic Area.  

This news comes just a week after Paige announced a $20 million round of funding, bringing its total raised to $95 million.

I spoke to Leo Grady, Ph.D., CEO of Paige, about what this clearance means for Paige, how it will increase the number of healthcare organizations using its technology and how this validates the work the company has been doing for the past three years. 

VatorNews: Explain to me exactly what this FDA clearance means for Paige. What can you do now that you couldn’t before? 

Leo Grady: FDA clearance is really critical in the medical field because what it means is that the FDA has determined that our software is safe and effective for its indicated use. And, in our case, that means using the viewer with images that have been scanned on a certain scanner, the Philips scanner, and to perform primary diagnosis from the images from the viewer. 

This is exciting for a lot of reasons. One thing is that, during COVID times, pathologists want to work from home, they want to be able to work remotely, they don't want to be in the lab, exposed to disease, to have other technicians handling slides and passing them around, giving them to the pathologists. At the same time, if they want to get a second opinion or to share a slide, they don’t want to have to touch it and put it in a bag and send it somewhere else. So, this is a really key technology for today, and it also is important that the slide viewer is fast, it’s responsive, that it works in a high-performing setting, because, if you are working from home, if you are working remotely, your bandwidth may not be so certain and it means that you’re going to be able to actually do your job effectively.

Now, the ability to work from home is something that is not going to be true once the emergency use period ends, because there’s still a law, which says, ‘The environment in which a pathologist works has to be a certified lab.’ But there’s a lot of momentum within the pathologist community to change that and, whether you’re sitting in a lab looking at a monitor, or you’re sitting at home looking at a monitor, it’s not really clear that it matters much, but when the law was written this was not really well conceived.  

Bottom line is that it’s huge for the pathology community, obviously it’s huge for Paige as well. 

VN: Why are you starting with the Philips Ultra Fast scanner? What was special about that one in particular?

LG:  We have a partnership with Philips, which is very exciting. Philips has been very forward thinking and outfront in getting their whole scanner and viewing system cleared for primary diagnosis. They were the first, back in 2017. So, they have really pushed the envelope in this field and so it made sense to start with them, to start with our partners.

The Paige system was designed to be able to incorporate images that were created from any scanner, from anybody. However, what the FDA has given us an indication for is specific to the Philips scanner at this point in time, although we do plan to add other scanners in the future.  

VN: What would have to happen for other scanners to be able to use Paige’s software?

LG: What would have to happen is we have to do a validation to ensure that what you see under a microscope, in terms of colors, in terms of fidelity of the tissue, is what you see on the monitor using our viewer. The FDA wants to make sure you're getting all the same information, and you're not blurring it, you're not compressing it and those sorts of things. 

VN: So you have to actually do a test with each specific scanner and make sure that your technologies are compatible with each one?

LG: That's right. But the test is fairly reasonable, and it's something that can be standardized. The concern that the FDA has is legitimate, in the sense that if something is going wrong with the optics of a scanner, or with the file handling from the viewer, then you can really expose a patient to getting the wrong diagnosis, which can have really catastrophic consequences for them. So, the FDA is appropriately concerned about that and they've done a very good job of putting in place these safeguards and protocols in order to ensure that fidelity.

VN: How many hospitals use the Philips scanner? How will this news increase the number of hospitals and health organizations using your technology?

LG: I don't have the data from Philips of all the different hospitals that use their scanners, but they are definitely one of the biggest players, if not the biggest player, in this space. And because they were the first to have FDA clearance, they've really transformed the market in the sense of pushing Philips for primary diagnosis and for scanning for primary diagnosis. They have quite an install base. 

Also, with our partnership with them, they will be selling Paige software in the future. That has not started just yetI don't want to put a date on it but they're not selling it just yet, and we also have the ability to sell our software, through our own salesforce at Paige.

VN: Having Phillips also selling your software will be a boon for the company I would imagine. How big of a deal is that for you?

LG: Yeah, it's amazing. Philips has a huge salesforce and they're obviously a multinational company, they're in every country. And our ability to tap into that sales channel is incredible. And, just to be really clear, they will be selling the Paige prostate solution. They're not going to be selling the viewer, specifically, but they will be selling Paige prostate, so they are slightly different. There's some nuance there.

VN: Can you tell me which other manufacturers you’re looking to work with beyond Philips?

LG: Our ambition is really to allow hospitals to buy whatever scanners they want. They all have different capabilities and serve different needs and, with whatever scanners they want, to be able to use Paige in order to do their primary diagnosis and, ultimately, take advantage of all of our digital diagnostic applications for prostate cancer and breast cancer and so on the future. So, our intention is to work with all of the scanner companies to get clearance for their scanners plus the Paige software. The timeline in which that happens is somewhat dependent on a lot of factors, such as getting data from those scanners and the FDA itself, but we're certainly working toward all of them and there are several big players in the field.

VN: What do you think getting this FDA clearance says about Paige and your technology? How validating is this for you?

LG: It's incredibly validating because it means that the software is ready for clinical use. It means that it's been tested, it's been validated, that it meets quality standards. So, this is not a toy, this is not a research project, this is a real clinical device and it meets all the standards that are necessary for use and treatment of real patients. The FDA, obviously, only has regulatory authority over the US, but they are the premiere body in the entire world for the evaluation of medical technology and they're known for how rigorous they are, and the way in which they evaluate new technology. So, even for hospitals in other countries, it really means a lot that we can say that the software has been subjected to, and passed, that level of rigor with the FDA.

VN: What would be the equivalent of getting this FDA clearance in Brazil?

LG: Brazil is also a different system, of course, and the FDA is incredibly well respected in Brazil in particular. We are working with our partners there, and exploring the possibility of getting clearance. Again, digital technology is something that is regulated differently in different areas, like a drug gets regulated more or less the same but digital is seen differently in different jurisdictions.

VN: Is there anything else I should know?

LG: One thing I can say about it is that everybody thinks of Paige as an AI company, as a computational pathology company, and of course it's definitely true and that's where we have distinguished ourselves. People are less aware that we have this enterprise imaging solution and the fact that we also inherited that solution from MSK, and that this technology has now been subjected to the rigor and the validation process from the FDA. With this announcement, we are going to start selling that in the US. 

This is both a coming out and a product launch for us, and I think it's going to really broaden people's perspective and perception of what Paige is. It's not just an algorithms company, it’s not just producing these kinds of exciting diagnostic technologies, it's really providing that infrastructure and that backbone to use that advanced technology as well. And so, Paige is a lot bigger and has a much richer offering than I think some people appreciated and this FDA announcement, I think, is going to really underline that and highlight it and make more people aware of the breadth of what Paige is doing, and offering in the space.