PathAI announced that the U.S. Food and Drug Administration (FDA) has qualified AIM-MASH AI Assist through the Drug Development Tool (DDT) Biomarker Qualification Program (BQP) for use within a context of use (COU) in metabolic dysfunction–associated steatohepatitis (MASH) clinical trials.
AIM-MASH AI Assist (formerly known as AIM-NASH before name change in the field) is the first AI-Powered pathology DDT to receive FDA qualification. The qualification follows the European Medicines Agency (EMA) CHMP qualification of AIM-MASH AI Assist earlier this year, underscoring PathAI’s regulatory leadership across both U.S. and European frameworks for AI-assisted histopathology in drug development.
AIM-MASH AI Assist has the potential to accelerate the development of new treatments by providing more efficient and accurate assessments of biopsy-based patient response to drug candidates within and across MASH clinical trials.
The FDA's DDT program enables biomarkers qualified for a specific context of use to enhance drug development. Per the FDA, drug developers may utilize this DDT for the qualified Context of Use (COU) in investigational new drug applications (INDs), new drug applications (NDAs), and biologics license applications (BLAs) submissions, thereby eliminating the need to resubmit DDT information or undergo additional CDER rereview. This is aligned to support the needs of biopsy-based enrollment and endpoint assessment, including for accelerated approval in the U.S., and conditional approval in the EU, in MASH clinical trials. This first-in-class AI-based DDT allows a single pathologist to provide standardized, accurate MASH biopsy assessments at scale.
AIM-MASH AI Assist is not for use in diagnostic procedures.
