NEW YORK – Ibex Medical Analytics on Monday said the US Food and Drug Administration granted 510(k) clearance to its in vitro diagnostic device Ibex Prostate Detect, which uses artificial intelligence (AI) to identify small and rare missed prostate cancers.
In a statement, the Tel Aviv, Israel-based company described the device as a "safety net that assists pathologists in ensuring patients receive an accurate diagnosis." Ibex Prostate Detect previously known in the US as Galen Second Read, analyzes scanned histopathology whole-slide images of hematoxylin and eosin (H&E)-stained, formalin-fixed paraffin-embedded tissue from prostate core needle biopsies. It is designed to detect tumors that may have been missed by a pathologist, and it alerts the pathologist, providing a heatmap of areas likely to contain cancer.
In validation studies, Ibex Prostate Detect had a 99.6 percent positive predictive value, and when using the test to reanalyze biopsies initially diagnosed as benign by pathologists, researchers found missed cancer diagnoses in 13 percent of samples. Those missed cancers were subsequently verified by pathologists, confirming the clinical utility of the test compared with the standard-of-care process.
"This [FDA] clearance affirms our commitment to the safety and efficacy of our AI solutions and strengthens our ability to provide cutting-edge innovation to pathologists, which ultimately benefit patients," Ibex CEO Joseph Mossel said in a statement. "We hope this accomplishment will bolster industry-wide confidence that AI-powered digital pathology is ready for widespread clinical adoption."
Ibex is also developing an AI-driven tool that assesses HER2 histochemistry scoring in breast cancer under a January 2023 agreement with AstraZeneca and Daiichi Sankyo. In March 2023, Alverno Laboratories began offering Ibex's Galen suite of AI-based tests, including the Galen Breast and Galen Prostate tests, to all pathologists in its networks. Those test have a CE-IVDR certificate in Europe and are used within 25 National Health Service trusts in the UK.