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

Rhea-AI Summary

Roche announced that its VENTANA DP 200 digital pathology solution has received FDA 510(k) clearance for diagnostic use. This clearance allows pathologists to use digital images for primary diagnosis, enhancing healthcare efficiency and patient care, especially in remote areas. The solution includes a slide scanner, workflow software, and a display, aiming to streamline digital pathology workflows. By enabling timely diagnoses from anywhere, this innovation supports greater pathologist collaboration and improved lab efficiency. Roche emphasizes its commitment to digital transformation and AI-based tools in pathology.

Positive

• FDA clearance for VENTANA DP 200 enhances Roche's reputation for innovation.
• Digital pathology improves efficiency and access to care in remote areas.
• Enables timely diagnoses and increased collaboration among pathologists.
• Supports Roche’s commitment to digital transformation and AI integration.
• Cleared solution can aid in diagnosing cancer, potentially boosting market adoption.

Negative

• Initial investment in digital pathology solutions may be high.
• Market acceptance and adoption of digital pathology technologies may face resistance.
• Dependence on FDA approval timelines can delay product launches.

• 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.

TUCSON, Ariz., June 18, 2024 /PRNewswire/ -- 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."

About Roche Digital Pathology
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.

About Roche 
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.

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.

All trademarks used or mentioned in this release are protected by law.

Roche Media Relations

Jo Lynn Garing, +1 317-363-7286

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SOURCE Roche

FAQ

What recent FDA clearance did Roche's VENTANA DP 200 receive?

Roche's VENTANA DP 200 digital pathology solution received 510(k) clearance from the FDA for diagnostic use.

How does the VENTANA DP 200 enhance healthcare efficiency?

The VENTANA DP 200 allows pathologists to use digital images for primary diagnosis, enabling timely diagnoses and improving lab efficiency, especially in remote areas.

What components are included in Roche's digital pathology solution?

Roche's digital pathology solution includes the VENTANA DP 200 slide scanner, digital pathology workflow software, and a display.

How does Roche's digital pathology solution benefit remote areas?

Roche's digital pathology solution expands access to pathologists in remote areas, allowing for timely and accurate diagnoses from anywhere.

What is Roche's commitment to digital pathology?

Roche is committed to digital transformation and the integration of AI-based tools in pathology to drive innovation and greater adoption in the field.