When the FDA Starts Trusting Algorithms: What AIM-NASH Means for Liver Drug Trials

when-the-fda-starts-trusting-algorithms:-what-aim-nash-means-for-liver-drug-trials

Regulators have just qualified an AI system to score liver biopsies in trials of a fast-growing liver disease. Behind the milestone lies a broader question: how far should drug development lean on algorithms that see what humans miss – and never get tired?

A quiet revolution in the liver lab

In most metabolic liver drug trials today, a patient’s fate – and often a company’s valuation – can turn on a few stained slivers of liver tissue.

Three experienced pathologists, working independently, review the same biopsy, grading fat, inflammation, ballooning of liver cells and the amount of scar tissue.

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