Summary: Roche’s VENTANA DP 200 whole slide imaging system has received FDA clearance for aiding pathologists in diagnosing patients through digital pathology.


  1. The VENTANA DP 200 system enhances pathology lab efficiency and enables remote diagnosis.
  2. This form of pathology facilitates collaboration and access to specialized pathologists for remote areas.
  3. Roche is integrating AI tools and promoting digital transformation within pathology labs to drive innovation.

Roche has announced 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 [this type of] pathology streamlines the digital workflow that empowers pathologists to make a timely diagnosis from anywhere,” says 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 digitalization of the traditional pathology workflow, starting from slide scanning, to visualization, to analysis. It 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 analyzed by pathologists and can help determine a cancer patient’s treatment. 

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

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