Digital Pathology Goes Mainstream

Enjoy the following content from our partner, Proscia.

COVID-19 has disrupted laboratory medicine in many ways, causing a strong need for new testing, social distancing, and telemedicine.

The pandemic has been especially challenging for pathology, which has remained mostly unchanged over the last 150 years. The field has held onto its traditional practices centering around a pathologist reading patient biopsies affixed to glass slides under a microscope in a laboratory environment. Now pathology faces a social distancing dilemma. Labs have been forced to limit on-site work to one or two pathologists at a time, resulting in some labs shipping slides to pathologists’ homes to keep up with the workload.

This need to work remotely has labs considering – and for some, reconsidering – digital pathology solutions. The discipline calls for capturing high-resolution images of tissue specimen, enabling pathologists to access and view cases on-demand from any location and easily share them for a second opinion. While the momentum behind digital pathology adoption has been building for some time, the unforeseen challenges of COVID-19 have served as a new catalyst for its adoption.

The Need for Digital Pathology

Labs that implemented digital pathology solutions pre-COVID have been able to work uninterrupted during the pandemic. So, why were only some labs prepared to take advantage of this opportunity?

Let’s look at the four critical factors that have helped shape digital pathology’s evolution: scanners, storage, software, and regulatory considerations. Early on, technology issues were a barrier to entry regarding the first three items. Scanners were clunky. Storage was expensive. And the software offered limited functionality.

Only more recently has information technology made it possible for laboratories to digitize. Scanners can handle the case volume. Storage is more affordable and flexible because of cloud computing. Software solutions are more robust, offering features for viewing, annotating, sharing, and analyzing images, including artificial intelligence (AI) applications. From automating time-consuming, manual tasks and prioritizing cases to centralizing pathology data, these features drive meaningful improvements in accuracy, efficiency, and quality, highlighting digital pathology’s value.

Before the pandemic declaration in March 2020, digital pathology had been gaining a foothold as laboratories could increasingly capitalize on its potential; however, the regulatory climate still held back full adoption. But after COVID-19 hit and it became clear that digital pathology was the solution for labs needing to operate remotely, the regulatory situation saw important relaxation. In April 2020, the FDA issued guidance that expanded the availability of remote digital pathology devices. This guidance, combined with a waiver issued in late March by the Centers for Medicare and Medicaid Services (CMS) that removes the validation requirements for viewing cases remotely, makes it much easier for pathologists to use digital pathology solutions for the primary diagnosis of cases at home. These regulatory relaxations are in effect only during the pandemic as of now, but it’s difficult to imagine that pathologists will not wish to continue along this path.

The Future of Digital Pathology

Today, many factors point toward digital pathology increasingly going mainstream. Laboratories are facing a surge in testing volume as patients return to their doctors. Meanwhile, there is a looming shortage of pathologists to handle this work. In fact, some pathology departments in the United Kingdom don’t have enough staff to push through their growing case volume – even when all pathologists are able to be in the laboratory.. Furthermore, published studies have validated the accuracy of using digital pathology in remote settings. Digital pathology would enable pathologists to read cases at home to keep pace while gaining all of the workflow efficiencies that it provides. A version of this article originally appeared in Clinical Lab Products under the title, “The Push for Digital Pathology.”

To learn more about digital pathology, I highly recommend attending the complimentary webinar, “2020 Fast-Tracked Digital Pathology – Trends and Approaches,” on October 8, 2020, at 11 AM PT. XiFin and Proscia experts will detail reimbursement trends, appeal strategies, operational and workflow approaches, how you can maximize the full potential of digital pathology, and much more.