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Roche Digital Pathology Algorithm for NSCLC Receives CE Mark

NEW YORK – Roche announced Friday its uPath PD-L1 (SP263) automated digital pathology algorithm for non-small cell lung cancer received the CE-IVD mark.

The algorithm uses artificial intelligence to offer one-click objective and reproducible automated assessments of scanned slide images that can help with diagnosis and targeted treatment options, the company said in a statement. It highlights positively and negatively stained tumor cells to determine if tumors are positive for the PD-L1 biomarker.

It was validated on the Ventana PD-L1 (SP263) Assay and is integrated within Roche's uPath software platform for case management and reporting. The algorithm is indicated for use with the Ventana assay in identifying patients for treatment with therapies with the greater than or equal to 50 percent PD-L1 TC positivity cutoff. It's the "first next-generation CE-IVD PD-L1 algorithm to the clinical market," Roche Diagnostics CEO Thomas Schinecker said.

Roche's uPath software was launched in 2019 and all algorithms in the suite provide image analysis of Ventana DP 200 scanned slide images stained with a Roche tissue assay, the company said.