EVEN AS THE WORLDWIDE COVID-19 PANDEMIC DERAILED SOME INDUSTRIES, it gave a major boost to digital pathology. That has meant an expanding market for Proscia, a seven-year-old provider of digital and computational pathology solutions.
Established in 2014, Proscia recently won what may be the world’s most important contract involving digital pathology and computational pathology solutions.
On Oct. 20, 2020, it was announced that the federal government’s Joint Pathology Center (JPC) in Silver Springs, Md., would use Proscia’s Concentriq platform for management of images and data, as well as collaboration among researchers. (See TDR, Oct. 26, 2020.)
In its repository, the JPC has more than 55-million glass slides, 35-million tissue block samples, and as many as 500,000 to 700,000 wet tissue samples. The pathology specimens date back to 1862.
Similarly, Proscia inked another significant agreement when, on Jan. 11, it announced that LabPON (Laboratory Pathology East Netherlands) of Hengelo, The Netherlands, would use Proscia’s Concentriq Dx, which carries the CE mark. LabPON is recognized as the world’s first lab to reach 100% digital pathology diagnosis.
“Our Concentriq software enables diagnostic labs and research organizations to view, manage, and analyze whole-slide images,” explained Nathan Buchbinder, Proscia Chief Product Officer and one of the company’s three founders. “Concentriq makes possible connection to applications such as whole-slide scanners and laboratory information systems, and launch of computational pathology and AI solutions. Currently thousands of pathologists and scientists use it.”
During 2020, despite the pandemic—or because of it—the steady increase in demand for digital pathology (DP) solutions and whole-slide imaging (WSI) was so robust that Proscia was able to raise $23 million in Series B funding last December. Scale Venture Partners was the lead investor, with participation from Hitachi Ventures.
Conjunction of Factors
Philadelphia-based Proscia appears to be benefitting from the conjunction of several factors behind the increased demand for digital pathology:
• Stay-at-home orders in the early months of the pandemic caused many pathologists to recognize how use of digital pathology and WSI could allow them to diagnose cases from their home offices.
• Research and pharma organizations are increasing their adoption and use of DP, WSI, and computational pathology solutions.
• Advances in image analysis and computational pathology are giving pathologists new tools to diagnose cancer and guide the selection of appropriate therapies.
“The number of pathology groups, labs and research organizations going digital has absolutely skyrocketed. I don’t anticipate that is going to stop when the pandemic does,” said Buchbinder in an exclusive interview with The Dark Report.
“Prior to the pandemic, there was growth in the DP market,” he continued. “Since the pandemic, the discussion has changed from one of ‘When should we do this?’ to ‘How do we make digital pathology happen for our lab?’ Not only are there more buyers, but there is urgency in their decision to implement a digital pathology system.”
Digital Pathology Systems
Clinical laboratories, as well as life science and pharmaceutical companies, are using digital pathology systems that include these elements:
• Whole-slide scanners for capturing digital images from glass slides;
• Software platforms for case review and viewing digital images; and,
• Computational pathology and artificial intelligence (AI) to generate insights from data.
Another development favorable to adoption of digital pathology was the federal Food and Drug Administration’s (FDA) “Enforcement Policy for Remote Digital Pathology Devices During the COVID-19 Public Health Emergency” issued last April. The agency relaxed requirements for use of digital pathology during the pandemic, giving pathologists the go-ahead to remotely review scanned images. Now, an FDA federal notice (86FR4088) filed in January, aims to make permanent the regulatory flexibility.
Also, the federal Centers for Medicare and Medicaid Services (CMS) waived requirements for remote locations doing pathology case sign-outs to have separate CLIA licenses during the pandemic. (See CMS memorandum QSO-20-21- CLIA: CLIA Labs Given Guidance During COVID-19 Public Health Emergency).
Buchbinder shared these additional insights with TDR during the interview.
EDITOR: From Proscia’s perspective, what are key healthcare trends in diagnosis and cancer care that benefit pathology groups?
BUCHBINDER: The biggest transformational trend is the broad adoption of digital pathology brought on by the recognition that there is an urgency to digitize. And the other trend is the ability to finally realize the potential of applications that use artificial intelligence (AI) or computational pathology to help the pathologist interpret the whole-slide images.
EDITOR: What is fueling demand for digital pathology?
BUCHBINDER: I see two factors driving adoption. One is the global pandemic and the other is growing enthusiasm around AI. We and a handful of other companies are at a stage now where we have lab clients deploying AI in practice and showing value creation from these products. This is on a trajectory to becoming routine in pathology practice. It is an exciting time for the DP industry and the anatomic pathology profession. We are excited to be in both realms and driving both trends.
EDITOR: What niche and segment of cancer is Proscia concentrating on with its product development?
BUCHBINDER: Our core digital pathology platform Concentriq can be used to view, manage, and analyze images of any type of tissue. It is meant to be a platform that can be used across any of the work a routine pathology lab performs. As a focus area in AI we have announced skin cancer, and we are focusing on a handful of other sub-specialties too. Broadly speaking, we see other companies working on high impact sub-specialties, which are either difficult to diagnose or time-consuming.
EDITOR: You mentioned other companies offering digital pathology solutions. What are Proscia’s strengths?
BUCHBINDER: We are strong in three key things. First, our DP platform is designed for use in multi-site enterprises, whereas other products are designed for single labs with single workflows. Our product is designed to accommodate labs with multiple sites and many pathologists working together.
Second, we are extremely pathologist centric. We have pathologists on our team who are involved in the day-to-day development of our systems and digital tools. Digital pathology systems need to complement the existing workflows of pathologists, even as use of the system makes those pathologists more productive. Third, we believe we are the only company sitting at the intersection of digital and computational pathology.
Support of Routine Workflow
EDITOR: Could you explain this?
BUCHBINDER: Yes. If someone builds an AI application, it is innovative technology that still needs to be put into practice. We built a platform designed to integrate with any third-party AI application—including those we are building—into routine workflows. Our goal is that the pathologist feels the AI is a natural extension of his or her digital pathology environment.
EDITOR: How do you develop AI?
BUCHBINDER: The first application we built is called DermAI. It serves the dermatopathologist by classifying images of skin biopsies into more than 200 unique diagnoses. We are deploying it for research use only today, but as we generate evidence of this product at laboratories, we are finding more and more value. It is kind of a harbinger of where the market stands today and where it is going. Building applications requires a lot of diverse data and validation work. We partner with leading academic and commercial laboratories: Johns Hopkins, University of California San Francisco, Thomas Jefferson University Hospital, and the University of Florida.
EDITOR: Please share examples of customers using Concentriq in clinical care.
BUCHBINDER: LabPON, which has already gone digital, is in the process of adopting our solution. They use digital pathology for every pathologist’s day-to-day work. When pathologists come in, rather than pulling out the microscope, they log in on the computer and look at their digital pathology system and their list of cases. They see whole slide image views and the diagnoses of their cases in that platform. So, their work has largely shifted from the microscope to monitor; from analog to digital.
EDITOR: When a lab or pathology group uses a digital pathology solution like Proscia’s on a case, how do Medicare and private insurers reimburse?
BUCHBINDER: In general, cases read using digital pathology are reimbursed the same way as cases read under the microscope. In fact, at the start of the pandemic, CMS expanded reimbursement to cover cases read digitally at home.
EDITOR: What factors would speed up adoption of digital pathology?
BUCHBINDER: There is a need for all the players in digital pathology to provide evidence of the value of digital pathology in patient care, along with DP’s potential to improve pathologist productivity and improve diagnostic accuracy. To show how digital pathology creates value for the lab, we collaborated with The Dark Report on a white paper, titled, “Pathology at the Tipping Point? The Economic Case for Adopting Digital Technology and AI Applications Now.”
The white paper demonstrates how adoption of digital pathology can improve lab productivity and efficiency by 13% to 21%. Evidence that demonstrates value can accelerate adoption of digital pathology. In the near future, we believe that pathology groups using digital pathology and related digital tools will have competitive advantage in the marketplace.
Contact Nathan Buchbinder at firstname.lastname@example.org; or Sydney Fenkell at email@example.com.