Roche granted FDA Breakthrough device designation for AI-driven companion diagnostic for non-small cell lung cancer

Roche announces that the U.S. FDA has granted Breakthrough Device Designation for the VENTANA TROP2 RxDx Device. This is the first Breakthrough Device Designation to be granted for a computational pathology companion diagnostic device.

“This FDA Breakthrough Device Designation is another example of our commitment to deliver innovation that enables more precise diagnosis in oncology,” said Matt Sause, CEO of Roche Diagnostics. “This solution, which leverages our industry-leading expertise in companion diagnostics development, uses artificial intelligence for a greater depth of sample analysis, helping to deliver truly personalised treatment.”

The VENTANA TROP2 RxDx Device is a computational pathology device, consisting of the TROP2 algorithm, navify Digital Pathology Image Management System, Roche Digital Pathology scanners and the VENTANA TROP2 RxDx Assay used with OptiView DAB Detection Kit for staining on a BenchMark ULTRA IHC/ISH staining instrument. The VENTANA TROP2 RxDx Device analyses whole slide images of non-small cell lung cancer tissue stained with TROP2 to compute a quantitative TROP2 score.

“This FDA Breakthrough Device Designation underscores the potential of our computational pathology platform to enable more personalised treatment decisions for people with cancer,” said Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca.

 

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Related Topics and Keywords

lung cancer, non-small cell lung cancer, Roche