The cover story in the September CAP TODAY features discussion with experts over the status of LDTs in the FDA and in other policies. Enforcement of RUO kits, marketing claims, direct-to-consumer special rules, still make a complex environment.
Find it here:
https://www.captodaymag.com/captoday/library/item/september_2025/4294593/
Digital Pathology Too
Also of interest, there's an article on the importance of huge pathology slide archives in the new AI world. And, an expert panel discusses momentum and issues in digital pathology.
All CAP TODAY articles are open-access.
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AI CORNER
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FDA and LDTs (CAP TODAY, Sept 2025, Karen Titus)
A federal court struck down the FDA’s sweeping plan to regulate laboratory-developed tests. The ruling focused only on the 1976 definition of "a medical device." Experts warn FDA authority remains and labs still face risks in areas like selling or using RUO products, Direct to consumer (DTC) testing, and intellectual property licensing.
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Digital Pathology Momentum (CAP TODAY, Sept 2025; Bob McGonnagle interviews)
Leaders from the Digital Pathology Association report rapid adoption of digital platforms, with institutions like Moffitt and Mayo moving to fully digital workflows. Panelists noted strong drivers—AI integration, workforce needs, and consolidation—though reimbursement gaps and uneven adoption across regions remain challenges.
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Pathology Archives and AI Future (CAP TODAY, Sept 2025, Ann Paxton)
The [US Military] Joint Pathology Center’s vast repository of 55–60 million slides and tissue blocks is being digitized to train AI tools for cancer, infectious disease, and rare disorders. Leaders expect these algorithms to improve diagnostic accuracy and speed, while also raising questions about data governance, ethics, and equitable access. In Silver Spring MD; see https://www.jpc.capmed.mil/
