FDA clears Roche’s digital pathology solution for diagnostics

The United States FDA granted Roche 510(k) clearance for the Roche Digital Pathology DX, a whole-slide imaging digital pathology solution to aid in diagnostics. The system includes multiple components, such as the VENTANA DP 200 slide scanner, digital pathology workflow software, and a display.

An article in Cureus defines whole-slide imaging as a component of digital pathology that uses scanning technology to generate digital images of entire glass slides. Healthcare professionals can then use the digitized images of slides to observe cell and tissue structures and make diagnostic conclusions.

According to the company’s press release, the tool’s primary goal is to assist pathologists in reviewing and interpreting digital images and scanned pathology scans to make patient diagnoses.

"Primary diagnosis for digital pathology streamlines the digital workflow that empowers pathologists to make a timely diagnosis from anywhere," said Jill German, Head of Pathology Lab for Roche Diagnostics. "This not only improves a pathology lab's efficiency but also expands access to pathologists for people living in remote areas and increases opportunities for pathologists to collaborate on patient cases."

The Digital Pathology Association emphasizes that digital pathology has many applications in healthcare, including primary diagnosis, diagnostic consultation, intraoperative diagnosis, student and resident training, manual and semi-quantitative review of immunohistochemistry, clinical research, diagnostic decision support, peer review, and tumor boards.

The tool that Roche has just received clearance for is focused on primary diagnosis.

The use of digital pathology technologies addresses multiple limitations of traditional pathology, including the barriers presented by the physicality and delicacy of glass slides, which make data sharing and transportation difficult. Additionally, digital pathology offers a way to minimize human error.

"We are investing in innovative digital pathology solutions to enable the pathology lab's digital transformation," German said. "Artificial intelligence-based tools and our Roche Digital Pathology Open Environment are designed to drive greater adoption and promote innovation in this critical field.”

Although the system received FDA clearance, the impacts on pathology pathways will not be apparent until it is utilized across health systems.