Roche’s momentum in digital pathology continues with FDA clearance on its high-volume slide scanner

• The VENTANA DP 600 slide scanner, part of Roche’s Digital Pathology Dx system, is now cleared by the FDA to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images.
• This 240-slide scanner produces excellent image quality of stained histology slides from patient tissue samples, while providing ease-of-use and workflow flexibility for the pathology lab.
• Primary diagnosis in digital pathology helps enhance diagnostic accuracy, consistency, and speed by providing high-resolution images and advanced analysis tools.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its whole slide imaging system, Roche Digital Pathology Dx, has received an additional 510(k) clearance from the United States Food and Drug Administration (FDA). This clearance modifies the one Roche received on June 14, 2024 for Roche Digital Pathology Dx, which includes the VENTANA DP 200 slide scanner, Roche’s digital pathology workflow software and a display, and now adds the VENTANA DP 600 slide scanner.

“The VENTANA DP 600 high-capacity slide scanner creates high-resolution, digital images of stained tissue samples that help clinicians diagnose cancer and determine a patient’s treatment, ” said Jill German, Head of Pathology Lab for Roche Diagnostics. “The recent FDA clearances continue our momentum to advance the pathology lab’s digital transformation and reinforce our commitment to enhance patient care and healthcare efficiency through streamlining the digital workflow.”

The VENTANA DP 600 has 40 times the capacity of the VENTANA DP 200 and uses the same scanning technology, providing pathologists with consistent, high quality images from both systems. Roche Digital Pathology Dx now includes the VENTANA DP 200 slide scanner, the VENTANA DP 600 slide scanner, Roche’s digital pathology workflow software and a display.

Roche Digital Pathology Dx is intended to aid the pathologist in reviewing and interpreting digital images of scanned pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue when diagnosing patients.

As the leading provider of pathology lab solutions, Roche is delivering an end-to-end digital pathology solution from tissue staining to producing high-quality digital images that can be reliably assessed using automated AI-based image analysis algorithms. We minimise variables that can impact analysis, and it is this end-to-end development that produces the quality results healthcare providers and researchers can depend on. With the acceleration of immunotherapy and the development of more complex assays, Roche is moving these traditionally research-oriented tools into routine clinical practice and is committed to investing in and shaping the future of pathology.

Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

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.

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