Ibex Medical Analytics announced today that it won CE Mark approval for its artificial intelligence-powered Galen Prostate software for identifying suspected cancer on prostate core needle biopsies.
Tel Aviv-based Ibex touts its Galen prostate solution as the first-ever AI-based software for cancer detection used in routine clinical practice, and it is already deployed in pathology labs looking to alert on missed cancer cases.
Ibex’s AI software is designed to help pathologists detect and grade cancer in biopsies. The Galen prostate system is a vendor-neutral AI solution evaluated across multiple scanning systems, staining platforms and pathology labs, according to a news release. It uses an algorithm developed from a dataset of more than 60,000 prostate slides that represented a variety of diagnoses and clinical findings.
Results from a clinical study showed that Ibex’s algorithm demonstrated the highest area under the ROC curve (AUC) reported in the field when compared to consensus diagnosis, as well as showing 98.6% sensitivity and 95.6% specificity, according to the news release.
“We are impressed with the results of the study, particularly with the performance of Galen Prostate, which was in near-perfect concordance with the consensus diagnosis between multiple pathologists,” Medipath head of innovation technologies and study participant Dr. Delphine Raoux said in the news release. “This solution can become an important tool for pathologists that look for ways to improve diagnostic quality and workflow efficiency.”
Ibex said the CE Mark approval will allow it to partner with leading institutes across Europe to implement the AI technology.
“We hit an important milestone with the CE-IVD Mark, facilitating a wider adoption of Galen Prostate in the market,” Ibex CEO Joseph Mossel said. “Cancer incidence and testing for cancer keep growing, with an impact on pathologists’ turnaround times and misdiagnosed cases. Ibex is committed to providing practical solutions that help pathologists meet these challenges.”