NEW YORK – Hot on the heels of securing US Food and Drug Administration marketing clearance for its digital pathology software, Proscia said it has created an alliance to guarantee that its products can work seamlessly as possible with its partners.
The Philadelphia-based firm said the Proscia Ready alliance is meant to encourage more diagnostic laboratories and life sciences firms to adopt digital pathology by assuring that the hardware and software components bought from alliance members are interoperable and that customers will receive support through a single contact.
In addition to Proscia, nine firms have signed onto the program: Barco, Dell Technologies, DoMore Diagnostics, Hamamatsu, Ibex Medical Analytics, Mindpeak, Pramana, Stratipath, and Visiopharm.
Nathan Buchbinder, cofounder and chief strategy officer for Proscia, said Proscia Ready is a commitment made by the firms rather than a service.
"This isn't something you have to sign up for as a laboratory," he said. "If you go with Proscia or any of the members of the Proscia Ready alliance, that commitment is made."
Proscia last month secured FDA 510(k) clearance for its Concentriq AP-Dx software, which is used to aid the viewing, interpretation, and management of whole-slide images. The software was cleared for use with the Hamamatsu NanoZoomer S360MD Slide scanner. The company said that Concentriq AP-Dx is the same as the firm's CE-IVDR certified Concentriq Dx software that is sold in Europe, cleared for marketing in the UK, and licensed by Health Canada.
Prior to announcing the Proscia Ready program, the firm had also struck multiple deals aimed at increasing digital pathology adoption. The firm signed in 2022 a multiyear agreement with Siemens Healthineers for that firm to combine its Enterprise Imaging offering with Proscia's Concentriq Dx platform. In 2021, Proscia also entered into a partnership with Unilabs to accelerate the adoption of artificial intelligence-based software into routine pathology practice.
Buchbinder said that the company's customers have described difficulties with creating and building employee confidence in systems that integrate slide scanners, software platforms, and, often, multiple image analysis applications. Laboratories can also face uncertainty in the components they select, limited protections for their investments, and increased overhead of working with multiple vendors.
Additionally, pathology department leaders have told Proscia that they want assurances that equipment and software makers will continue developing cooperative products, Buchbinder said. The firms in the Proscia Ready program have agreed to maintain product compatibility and share product roadmaps.
"The reality is that for a lab that is looking to adopt digital pathology at scale, they need that confidence that when they run into trouble or when they're looking to plan for the future, they're not going to get a copy (and) paste answer of 'Yes, we integrate with X' or 'Yes, we're interoperable with Y,'" he said.
Matthew Hanna, board member for the Digital Pathology Association and vice chair of the College of American Pathologists' Artificial Intelligence Committee, said interoperability has been a major issue during the ramp-up of digital pathology adoption. Many of the companies in the space initially developed siloed platforms, but as digital pathology has matured, he has seen more efforts toward collaboration as well as promises to end users that components will work together.
"Ultimately, what we really need is industry-level standardization, so it's not just Proscia and nine companies, it's every hardware and software vendor, and I think that's where we're headed, hopefully," Hanna said.
Outside the Proscia-led alliance, companies such as Philips and Roche have been offering hardware and software combinations that are meant to give labs integrated digital pathology systems. Roche has also inked deals with digital pathology software firms PathAI and Ibex, and Philips said on its website that it offers interoperability with third-party AI applications to aid digital pathology workflows. Paige also secured marketing clearance for its FullFocus digital pathology image viewer with the Philips Ultra Fast Scanner.
Buchbinder said Proscia's customers will want different combinations of components depending on their lab's priorities, which may include greater investments into specific applications such as AI-assisted breast cancer panels for HER2, ER, PR, and Ki67, or the identification of candidate biomarkers during drug discovery. Proscia formed its Proscia Ready program, keeping in mind companies whose technologies are already widely adopted by Proscia's customers. However, he said that other firms in the space have also reached out about potentially signing.
Kimberly Gasuad, senior VP of business development and strategy for Ibex, said her company's AI-based Galen digital pathology platform for cancer diagnosis and biomarker scoring is designed to be agnostic to the equipment used to capture images or view them. However, customers remain concerned about interoperability, especially anatomic pathology lab customers who want to integrate Ibex's software with existing infrastructure.
"Part of resolving that concern for labs and our end users is to partner with companies like Proscia," she said.
Proscia and Ibex have already been collaborating since a 2021 agreement on the joint development of an integrated product for AI-based prostate cancer diagnosis. Ibex also inked a deal last year to offer its tools on Roche's Navify Digital Pathology software platform.
As the alliance grows, it will include companies that view each other as competitors, Buchbinder said.
Hanna, who is not connected with Proscia or the Proscia Ready program, said a lack of standards for interoperability in digital pathology has been a barrier to its adoption. However, he said radiology solved a similar problem decades ago through industrywide adoption of the Digital Imaging and Communications in Medicine (DICOM) standard for imaging file formats and communication protocols.
He noted that DICOM has also published a standard for imaging in pathology.
On Proscia's website, Buchbinder said that the firm is committed to using the DICOM standard for image storage and transmission rather than the use of proprietary image formats because use of the DICOM standard allows seamless integration between different digital pathology systems and the exchange of images and metadata.
Buchbinder said that in addition to offering laboratories assurances of interoperability, Proscia sees the potential that the Proscia Ready program can help guide them through digitization, hasten their adoption of digital pathology technologies, and give them the features they need to be "not just live but growing in their utilization and in the value creation that they see from digital" pathology.