Roche gains 501(k) clearance for digital pathology solution for diagnostic use

Original from: Medical Device Network

Roche has announced that the US Food and Drug Administration (FDA) has granted 501(k) clearance for the diagnostic use of its whole-slide imaging system, Roche Digital Pathology Dx.​

The system includes Roche’s VENTANA DP 200 slide scanner, digital pathology workflow software, and display.

Digital pathology systems evolve traditional pathology workflow, end-to-end from the scanning of tissue slides through to sample visualisation and subsequent analysis.

Roche has said its system scans at 20x magnification in less than 49 seconds and  40x magnification in less than 85 seconds for 15 mm x 15 mm areas of interest (AOIs), and that its ability to load slides for scanning using a tray-based system eliminates slide-handling errors and improves reliability.

VENTANA DP 200 was launched in 2022 with a CE mark for in-vitro diagnostic use in Europe. The system was previously available in the US for research use only (RUO).

Head of Pathology Lab for Roche Diagnostics, Jill German, said: “Primary diagnosis for digital pathology streamlines the digital workflow that empowers pathologists to make a timely diagnosis from anywhere.

“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.”

Roche recently also announced it had received emergency use authorisation (EUA) from the FDA for its cobas liat SARS-CoV-2, Influenza A/B and respiratory syncytial virus (RSV) nucleic acid test, with plans to seek 501(k) for it in future.

Other high-resolution imaging solutions for cancer detection in tissue samples which have received 501(k) clearance from the FDA this year include Proscia’s Concentriq AP-Dx pathology system and Enspectra Health’s non-invasive skin imaging VIO System.​

Source: Roche gains 501(k) clearance for digital pathology solution for diagnostic use