Tel Aviv, Israel, May 26, 2021 - Ibex Medical Analytics, the pioneer in AI-powered cancer diagnostics, today announced CE Mark for the Galen™ Breast solution for use in supporting pathologists in detection of various types of breast cancer. The solution is now generally available as Ibex partners with laboratories, hospitals and health systems to implement artificial intelligence (AI) technology into the diagnostic workflow. Galen Breast has already been ordered by multiple labs, including a network-wide deployment at a leading pathology group in Europe.

The CE Mark follows pioneering results from a blinded, multi-site clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel. Galen Breast demonstrated very high accuracy in detecting various types of breast cancer, including invasive and in-situ cancers, distinguishing between different types of invasive cancer (e.g., lobular versus ductal carcinoma) and grading of DCIS lesions. These results validate the robustness of Galen Breast and support its adoption by pathology institutes that aim to improve their diagnostic accuracy by enhancing quality control with AI.

Breast cancer is the most common malignant disease in women worldwide, with over two million new cases each year. As such, accurate and timely diagnosis of breast cancer is instrumental in guiding treatment decisions and improving patient survival rates. Additionally, over the last several years there has been an increase in the number of cancer cases and together with rapid advances in personalized medicine, this has resulted in increases in the complexity of cancer diagnosis. Coupled with a global decline in the number of pathologists, these trends have led to growing workloads imposed on pathology labs and health systems. Clearly, there is a growing need for automated solutions and decision-support tools that help pathologists detect cancer to the utmost accuracy more rapidly, while enabling comprehensive and affordable quality control.
Ibex transforms cancer diagnosis by harnessing unique artificial intelligence (AI) and machine learning technology at an unprecedented scale. Galen Breast is the first AI solution used for detection of breast cancer in pathology. It was developed utilizing state-of-the-art AI and machine learning techniques, and was trained on hundreds of thousands of image samples, scanned from biopsy slides digitized using digital pathology. Galen Breast is already deployed in routine clinical practice at multiple pathology labs globally where it is used as a second read application for real-time quality control, helping pathologists improve diagnostic accuracy.

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