UTHSC Professor is advisor to a company that just got an FDA 510(k) clearance
The Ibex Prostate Detect is a software only device that analyzes scanned histopathology whole slide images (WSIs) from prostate core needle biopsies.
A company whose Scientific Advisor is a Clinical Professor of Pathology and Laboratory Medicine at the University of Tennessee Health Science Center (UTHSC) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Ibex Prostate Detect.
The company is named Ibex Medical Analytics and the new product is an in vitro diagnostic medical device that harnesses AI to generate heatmaps identifying small and rare missed prostatic cancers, acting as a safety net that assists pathologists in ensuring patients receive an accurate diagnosis.
Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, has announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for Ibex Prostate Detect, an in vitro diagnostic medical device that harnesses artificial intelligence (AI) to generate heatmaps identifying small and rare missed prostatic cancers, acting as a safety net that assists pathologists in ensuring patients receive an accurate diagnosis.
“Prostate cancer is one of the most prevalent cancers worldwide, with an estimated one in eight men diagnosed in their lifetime,” said Mahul B. Amin, MD, Vice President and Medical Director of Labcorp’s Hospital Systems Operating Division who is also a UTHSC Clinical Professor. “With the global incidence expected to double by 2040, accurate and timely diagnoses are more critical than ever. Advancements in AI-powered pathology can support pathologists in delivering precise and efficient diagnoses, ultimately improving patient outcomes.”
Ibex Prostate Detect is a software only device that analyzes scanned histopathology whole slide images (WSIs) from prostate core needle biopsies prepared from hematoxylin and eosin (H&E) stained formalin-fixed paraffin embedded tissue. The device is intended to identify tumors that may have been missed by the pathologist. If tissue suspicious for prostate cancer is identified, the system provides case- and slide-level alerts, and includes a heatmap directing the pathologist to areas likely to contain cancer.
In robust precision and clinical validation studies conducted at multiple U.S. and European laboratories as part of the FDA clearance, the system demonstrated a 99.6 percent positive predictive value (PPV) for cancer heatmap accuracy, and identified a 13 percent rate of missed cancers in a cohort of consecutive patients initially diagnosed as benign.
These missed cancer cases (false negatives) were subsequently verified by expert pathologists, confirming the product’s clinical utility and benefits compared with the current standard of care.
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