Ibex Medical Analytics has announced CE marking for the Galen Gastric solution that supports pathologists in the detection of various types of gastric cancer.
With this first-of-its-kind solution becoming generally available, Ibex offers the richest portfolio of artificial intelligence (AI) solutions in pathology, enabling detection of cancer and other pathologies in gastric, breast and prostate biopsies.
Gastric cancer is a prominent malignant disease in both men and women worldwide, with over a million new cases every year and a relatively poor prognosis. Pathologists play a crucial role in the detection and diagnosis of gastric cancer, with their assessments being vital for reaching correct treatment decisions by oncologists and improving patient survival rates.
The Galen suite of solutions is the most widely deployed AI technology in pathology, and Ibex now partners with laboratories, hospitals and health systems to implement AI for the diagnosis of gastric biopsies. Galen Gastric is an integrated diagnostics solution that supports pathologists in the detection of gastric cancer, Helicobacter pylori and other important clinical findings and in enabling shorter turnaround times and optimised diagnostic workflows1. The solution was developed by a team of pathologists, data scientists and software engineers who implemented advanced Deep Learning technologies and trained algorithms on more than a million image samples, scanned from biopsy slides digitised using digital pathology.
The CE mark follows pioneering results from a blinded, multi-site clinical study at Medipath, the largest pathology network in France, and at Maccabi Healthcare Services, the second largest health network in Israel. Galen Gastric demonstrated very high accuracy in detecting various types of gastric cancer, as well as H. pylori (a common gastric bacterial infection and a precursor for cancer), neuroendocrine lesions, dysplasia, adenoma and additional pathologies. These results validate the robustness of Galen Gastric and support its adoption by pathology institutes that aim to improve diagnostic quality and enhance productivity.
“We are proud to obtain this first-of-its-kind CE mark for AI-powered GI diagnostics in pathology, following excellent performance in a multi-site clinical study,” said Dr Chaim Linhart (Co-founder and CTOat Ibex Medical Analytics). “We trained the Deep Learning models of Galen Gastric on more than a million image samples from multiple laboratories to ensure it can accurately detect not only cancer but also a multitude of other clinically relevant features that impact future treatment for patients. Ibex now offers an unprecedented breadth of clinical applications, and this approval will enable our growing customer base to expand the usage of AI technology and provide pathologists with new insights as they review gastric biopsies, improving the quality of cancer diagnosis and care.”