Proscia Inc., a Philadelphia-based company that focuses on artificial intelligence (AI)-enabled digital pathology solutions, recently made the Concentriq Dx digital pathology software available for use in reviewing and reporting of digital pathology slides in the U.S. during the COVID-19 pandemic.

Digital pathology involves the digitizing of glass slides using a whole slide image scanner and then analyzing the images on a viewer – typically on a computer monitor or mobile device. The viewer works much in the same way as a traditional standard light microscope. And even though basic viewing functionality has not changed drastically in recent decades, digital pathology has led to lab efficiency, workflow and revenue enhancements.

However, current practice ties pathologists to microscopes in physical laboratory spaces. That represents a problem during this pandemic, which has led to disruption at these facilities, affecting the ability to serve patients. But there is hope, as the U.S. FDA last month introduced guidance on a policy to help expand the availability of remote digital pathology devices while protecting health care personnel against the risk of exposure to COVID-19.

The FDA noted, however, its policy is intended to remain in effect only for the duration of the public health emergency related to the pandemic, as declared by the Department of Health and Human Services.

Still, Proscia has a role to play, as Nathan Buchbinder, co-founder and chief product officer of the company, told BioWorld. Of note, the company has two versions of Concentriq, one of which is geared toward research at life sciences and pharma companies, as well as helping CROs and academic sites.

Concentriq Dx digital pathology software. Credit: Proscia Inc.

Concentriq Dx, which is for sale for clinical use in Europe and had not yet been offered in the U.S. in a meaningful way, now may be available to labs as a result of the FDA’s action. This includes labs that have been using its research-only product, as well as groups with which the company has had future-looking conversations.

Specifically, Concentriq Dx permits pathologists to read cases from remote locations securely, including home offices, using an Internet browser. The software works with any scanner and laboratory information system.

“It’s been stellar,” Buchbinder replied when asked about how the European response has been thus far. He noted that there have been labs that have never considered digital pathology, in addition to those that were early adopters. “The response has been very, very strong. And we take a … more modern approach to software development and introduction. Software is our only focus, compared with most of our competitors out there.”

This focus has led to an experiential change in terms of how pathologists operate in a digital ecosystem. To that end, Proscia can provide an intuitive experience and interface.

Just this year, the company has seen big partnerships. For example, in March, it reported a partnership with Visiopharm to deliver AI-enabled solutions that aim to drive breakthroughs in translational research and advance precision medicine. The duo also established a global reseller and support agreement to accelerate the delivery of these combined offerings to the market.

Earlier that same month, Proscia and the University of California at San Francisco said they were partnering, with their initial focus being prostate cancer.

A large space

“The digital pathology space is quite big,” Buchbinder explained. “We’ve seen double-digit growth for the past five or so years in terms of adoption of digital pathology in both research and clinical labs. In fact, the use in clinical practice has been growing faster – I think 17% – as compared to the research space.”

He noted that there is great potential in North America and Europe. And while it has not caught on in other geographies at this time, he thinks it is only a matter of a couple of years until it does.

The company is eyeing the FDA for a regulatory signoff and views the agency’s response to COVID around digital pathology solutions “as one of the things that’s going to help drive not just our evidence-generation in support of future filings,” but also ensure the market is aware of and interested in adopting digital pathology in routine day-to-day practice, Buchbinder concluded.