FDA qualifies its first AI drug development tool, PathAI's liver biopsy scorer
The FDA qualified PathAI's AIM-MASH AI Assist through its Drug Development Tool biomarker qualification program. The agency calls it the first AI drug development tool it has qualified. The cloud-based software scores liver biopsy images for steatosis, ballooning, lobular inflammation and fibrosis stage in MASH clinical trials, using the NASH Clinical Research Network system. Pathologists review and accept or reject every score. PathAI says the model was trained on more than 100,000 annotations from 59 pathologists and 5,900 biopsies from six MASH trials.
Why it's notable: In MASH trials, several pathologists usually read each biopsy by hand, and their scores often disagree. The FDA says a qualified AI reader could make that assessment more consistent and cut the time and cost of developing MASH drugs. It is also the first regulatory path for using AI to measure a trial endpoint.