Roche Receives CE Mark for Digital Pathology Algorithm to Aid Breast Cancer Diagnosis
Roche has received the CE mark for its uPath HER2 Dual ISH digital pathology algorithm, enabling its clinical use in Europe. The software is designed to support pathologists in assessing HER2 gene amplification in breast cancer samples, helping to standardize and streamline diagnostic workflows. This regulatory approval marks a step forward in digi...
- Published date: 16-07-2026 10:02 AM
Roche announced in June 2024 that its digital pathology algorithm, the uPath HER2 Dual ISH image analysis, has received the CE mark, allowing its use in Europe. This algorithm is designed to assist pathologists in evaluating HER2 gene amplification in breast cancer tissue samples.
The CE mark certifies that the software meets European Union safety, health, and environmental protection requirements. The algorithm integrates with Roche’s uPath enterprise software and the VENTANA HER2 Dual ISH DNA Probe Cocktail assay, supporting more standardized and efficient diagnostic workflows.
Roche stated that the digital tool aims to improve consistency and accuracy in HER2 testing, which is critical for determining eligibility for targeted therapies in breast cancer patients. The company plans to make the algorithm available to laboratories across Europe following this regulatory milestone.
Roche has received the CE mark for its uPath HER2 Dual ISH digital pathology algorithm, enabling its clinical use in Europe. The software is designed to support pathologists in assessing HER2 gene amplification in breast cancer samples, helping to standardize and streamline diagnostic workflows. This regulatory approval marks a step forward in digital pathology adoption for breast cancer care.