A flurry of brief items in digital pathology.
Tailwinds!
The Israeli company IBEX gets FDA approval for Prostate Detect, an AI system based on H&E whole slide imaging (WSI) to detect missed prostate cancers. Discussion at PMO Precision Medicine Online - here. Also noted at Katie Maloney's Decibio article on Linked In here.
Tracking a couple other items from Katie Maloney. She writes about TEMPUS collaborating with IMAGENE bring together molecular profiling with "H&E based biomarkers." Here. Separately, see also TEMPUS again, this time with ARTERA here.
Maloney also discusses companion diagnostics from digital pathology, with nods to Roche, AstraZeneca, Leica, and Indica. Here.
AstraZeneca discusses its deep interests in digital pathology diagnostics; iinterview here.
Headwinds??
Over at AMA CPT, potential changes to PLA coding rules were on the publicly posted agenda for the February meeting last week. Results of changes, if any, won't be published by AMA until September, meaning, the 2026 code book.
##
AI CORNER
##
Some of the news items, AI summaries, Chat GPT 4o. See full details at the links above. See also more Dig Path articles by Katie Maloney.
AI and Digital Pathology: The Next Frontier in Precision Medicine
AI-driven digital pathology continues to gain momentum. Ibex Medical Analytics secured FDA 510(k) clearance for Prostate Detect, an AI tool assisting pathologists in detecting missed prostate cancers. This marks a major step in computational pathology, making Ibex the second company, after Paige, to receive FDA clearance, though reimbursement remains a challenge.
Meanwhile, Tempus AI and Imagene are combining H&E-based biomarker prediction with NGS, streamlining AI-powered oncology diagnostics. In companion diagnostics (CDx), major partnerships like Roche-AstraZeneca and Leica-Indica Labs are accelerating progress toward DP-based CDx applications. These developments highlight the increasing convergence of AI, pathology, and molecular diagnostics, with data validation remaining the key hurdle.
As AI-powered tools become more sophisticated, the industry moves closer to integrating digital pathology into routine clinical practice, paving the way for enhanced diagnostic accuracy and personalized medicine. The question now is: Are we at the tipping point for digital pathology CDx?
