NEW YORK ─ After receiving 510(k) clearance for its image viewing software, New York-based Paige is working toward receiving additional regulatory clearances for its artificial intelligence-based digital pathology products, and increasing the adoption of digital pathology workflows.
The US Food and Drug Administration in July cleared the firm's FullFocus viewer software for viewing and management of digital images of scanned surgical pathology slides obtained using the Philips Ultra Fast Scanner. The viewer and other products in Paige's product development pipeline have the potential to push broader acceptability of digital pathology products, Carla Leibowitz, Paige's chief business development officer, said in an interview.
The FDA greenlighted FullFocus to help pathologists review, interpret, and manage digital images of tissue slides for primary diagnosis. The image viewer allows pathologists to securely view scanned images in the cloud from different geographic locations and from their homes during the emergency-use period, Leibowitz said.
The clearance is important to Paige partly because the viewer can "serve as a delivery vehicle for other advanced technology we're building," Leibowitz said. The company, founded in 2018 to leverage technology developed at New York-based Memorial Sloan Kettering Cancer Center, has "multiple projects in its pipeline to develop digital biomarkers and other pathology solutions that help doctors find, characterize, grade, and measure cancer tissue on images," she added.
Just over a week before getting the nod from the FDA, the company announced it had received $15 million in Series B funding from Goldman Sachs' Merchant Banking division, bringing Paige's total Series B funding to $70 million and its total capital raised to more than $95 million.
"The goal overall is to grow faster and build faster … and with the additional funding we can accelerate that," Leibowitz said. The firm is using the financing to continue developing cancer pathology workflows, including projects with biopharma companies to create custom digital pathology diagnostic products for clinical trials. In the biopharma space, its goal to develop AI-based companion diagnostic tests to provide insights into patients' responses to drug treatments and determine whether their cancers are aggressive, Leibowitz said.
Further, the digital pathology company is continuing to develop artificial intelligence-based products to help practicing pathologists detect breast cancer and evaluate suspected metastases in lymph nodes. An AI-based prostate cancer detection product that received CE marking in 2019 along with the FullFocus viewer is in the pipeline for US launch "upon FDA clearance," Leibowitz said, but didn't provide a more specific anticipated timeline for clearance and launch. Both the prostate cancer detection system and viewer are vendor-neutral products, meaning pathologists can view digitized slides from different sites and different brands of slide scanners.
Patricia Raciti, a board-certified, practicing general pathologist who works for Paige, said in an interview that the firm's first product to receive FDA clearance, the FullFocus viewer, helps pathologists with the goal of "making an accurate diagnosis in a time-efficient manner."
The viewer was designed with input from pathologists from a variety of backgrounds who have a detailed understanding of the specific tasks associated with the pathology practice, and it "helps make those tasks more efficient," Raciti said.
Apart from viewing of slides from which pathologists diagnose cancers, the platform enables access to the stored digital pathology images in the cloud, Raciti said. "The storage capability is important because digitized slides take up so much storage space and they need to be stored securely and in a way that they can be quickly accessed, as quickly as glass slides," Raciti said. The FullFocus viewer is designed to allow integration with AI products that Paige is developing, which is important for the future adoption of those products, she added.
Paige was launched to commercialize technology developed by company cofounder Thomas Fuchs and his colleagues, leveraging a license agreement with MSK. Under the license agreement, the company received 1 million de-identified images of digitized slides and began digitizing additional slides from MSK's archives to develop its portfolio of AI-based products.
In 2019, Fuchs and his colleagues described the development of an approach to speed up the development of clinical-grade, deep learning-based computational pathology systems by evading the time-consuming process of manually annotating slide images. The approach, published in Nature Medicine, addresses a need for more effective decision support systems that cancer pathologists can use in clinical practice.
Paige has further developed the system, writing commercial-grade code, building quality management systems, and embarking on regulatory and business activities. In 2019, the FDA granted Breakthrough Device Designation for the company's AI-based pathology tools.
The FullFocus viewer was initially developed and validated at MSK to allow researchers and pathologists to view and navigate digital images of surgical pathology slides acquired on all main whole-slide imaging scanners used by hospitals. Based on feedback by dozens of practicing pathologists using the viewer at MSK, Paige further developed the viewer to meet the performance requirements for IVD use.
Pathology during COVID
Pathology labs, hospitals, and biopharma companies need the viewer to serve patients and conduct research with little disruption, sometimes without pathologists being in their labs, Leibowitz said.
The viewer helps them overcome challenges with on-premise storage and lack of interoperability ─ including dealing with different file formats from different scanners, she said.
Leibowitz added that the clearance of its viewer with the Philips Ultra Fast Scanner also paves the way for the in vitro diagnostic use of FullFocus with additional whole-slide imaging scanners.
The Ultra Fast Scanner is part of the Philips IntelliSite Solution, a clinical digital pathology system that is cleared for IVD use in several countries. Philips was the first company to go to market with an FDA-cleared digital pathology system. The firm received clearance for its IntelliSite Pathology Solution in 2017, and in May last year, Danaher's Leica Biosystems received FDA clearance for its Aperio AT2 DX digital pathology system.
Stephan Fromme, director of digital and computational pathology growth initiatives at Philips, noted that it is developing open pathology platform products, that enable "pathologists and researchers to unlock the power of digital pathology." Paige utilizes a software developers' kit that Philips provides to third parties, he said. The kit enables fast acquisition and interpretation of image pixels produced by the Philips scanner for third-party digital pathology image viewers and for AI-based image-analytics software, to support pathologists in their assessment of tissue.
The file format used by Philips and Paige is called iSyntax, a medical-grade imaging file format designed for digital pathology and comparable with different consumer file formats like JPEG, PNG, and BMP. "Interoperability and the expansion of the iSyntax ecosystem benefit pathology laboratories and will further the adoption of digital pathology," Fromme said.
Philips last year announced it is collaborating with Paige on clinical-grade artificial intelligence technologies for pathology labs. The AI technologies, starting with Paige Prostate software, aim to help pathologists identify, quantify, and characterize cancer in tissue samples and make precise diagnoses more efficiently.
With the coronavirus pandemic, pathologists were confronted with a new challenge as they were unable to work from their labs. To meet that obstacle, in March, the Centers for Medicare and Medicaid Services granted a temporary waiver allowing pathologists to review slides remotely during the SARS-CoV-2 pandemic.
In April, Philips and Danaher's Leica Biosystems both announced that they received enforcement discretion from the FDA, allowing pathologists to use their technology to work remotely during the coronavirus pandemic.
Following clearance for its FullFocus viewer, Paige sees the potential for its broad use during the pandemic. "Pathology work has changed in a couple of ways," Leibowitz said. "A lot of surveillance and screening procedures have been paused, so patients have been delayed in getting procedures such as mammograms and prostate exams, and the pathology workload dropped accordingly, especially during the first three to four months of the pandemic." With surveillance and screening procedures coming back online, pathologists have a backlog of work they need to get through from their homes, she noted.
In this context, the cleared software enables the distribution of pathology imaging viewing and analysis procedures among teams. "It opens opportunities to transform the practice of pathology into a digital practice without incurring huge capital costs, which has been one of the reasons why adoption has been slow in the last few years since the first FDA clearance," Leibowitz said.
Paige did not disclose pricing for use for its image viewer, saying it is based on the file size and number of images and number of system users associated with an institution.
With the clearance of the digital pathology viewer during the pandemic, Leibowitz said "pathologists have the tools they need to continue doing their work, helping patients and not delaying diagnoses."