The AI-powered pathology tool becomes the first AI-based drug development tool to receive FDA qualification, following earlier EMA approval.
PathAI announced that the US Food and Drug Administration (FDA) has qualified AIM-MASH AI Assist through the Drug Development Tool Biomarker Qualification Program for use in metabolic dysfunction–associated steatohepatitis (MASH) clinical trials.
The qualification makes AIM-MASH AI Assist the first AI-powered pathology drug development tool to receive FDA qualification, according to a release from PathAI. The approval follows the European Medicines Agency CHMP qualification of the same tool earlier this year, establishing regulatory approval across both US and European frameworks for AI-assisted histopathology in drug development.
The FDA’s drug development tool program enables biomarkers qualified for a specific context of use to enhance drug development. Drug developers may utilize this tool for the qualified context of use in investigational new drug applications, new drug applications, and biologics license applications submissions, eliminating the need to resubmit drug development tool information or undergo additional CDER review.
Supporting MASH Clinical Trial Efficiency
The qualification aims to offer a more efficient, standardized, and reproducible approach to evaluating liver biopsies during enrollment and endpoint assessment in MASH clinical trials. PathAI says the tool 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.
“Dual qualification by the EMA and the FDA gives sponsors a regulator-approved path to use AI-assisted histology for Phases 2 and 3 MASH clinical trial enrollment and endpoint assessment. For MASH trials worldwide, that means greater consistency, reproducibility, and confidence in histologic endpoints,” says Naim Alkhouri, MD, FAASLD, in a release.
The qualification allows pathologists to provide standardized, accurate MASH biopsy assessments at scale, supporting biopsy-based enrollment and endpoint assessment, including for accelerated approval in the US and conditional approval in the EU, according to the company.
Validation Foundation
The FDA qualification builds on analytical and clinical validation that demonstrated non-inferiority to average individual pathologist reads for fibrosis and steatosis, superiority to individual expert manual reads for ballooning, inflammation, and clinical trial enrollment and endpoint criteria, and superiority for reproducibility compared to manual reads across every precision metric tested.
“We’re proud to have worked collaboratively with FDA, EMA, industry partners, and advisors to achieve the initial FDA and EMA qualification of an AI-based biomarker via their biomarker qualification programs,” says Andy Beck, MD, PhD, co-founder and CEO of PathAI, in a release. “Dual recognition from US and EU regulators underscores our commitment to rigorous validation and responsible deployment of AI to transform pathology and improve patient outcomes.”
AIM-MASH AI Assist is qualified as a tool in the EU and as a drug development tool in the US for use in MASH clinical trials. The tool is not for use in diagnostic procedures.
PathAI is a provider of AI-powered pathology solutions that aim to improve the accuracy of histology assessment and accelerate drug development. The company is headquartered in Boston.
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