Roche receives FDA clearance on its digital pathology solution for diagnostic use

• The solution, which includes the VENTANA DP 200 slide scanner, Roche’s digital pathology workflow software and a display, is now cleared to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images.
• Primary diagnosis for digital pathology enhances healthcare efficiency and helps ensure effective and timely patient care, especially in areas where access to pathologists is limited.
• This clearance is a foundational step in Roche’s commitment to enable routine clinical diagnosis with its digital pathology solutions.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its whole-slide imaging system, the Roche Digital Pathology Dx (VENTANA DP 200), has received 510(k) clearance from the United States Food and Drug Administration (FDA). The system is intended to aid the pathologist in reviewing and interpreting digital images of scanned pathology slides to help diagnose patients.

“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.”

Digital pathology refers to the digitalisation of the traditional pathology workflow, starting from slide scanning, to visualisation, to analysis. Digital pathology is transforming traditional histopathology by improving efficiency, depth of analysis, and opportunity for collaboration in pathology workflows. For example, once a slide scanner captures and converts stained tissue on glass slides to digital images, these images can be managed, shared, and analysed by pathologists and can help determine a cancer patient’s treatment.

“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.”

In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

SOURCE: Roche Diagnostics