New FDA PathologAI Initiative

The FDA National Center for Toxicological Research says its PathologAI initiative is intended to develop an effective and accurate framework for the analysis of histopathological data from animal studies to advance digital pathology in preclinical application. An online post says PathologAI “may quickly and accurately identify and quantify specific lesion types. It may also quantitatively evaluate morphologically relevant regions of interest to facilitate pathologists’ reviews in the preclinical setting.”

The post describes PathologAI as a multi-stage deep-learning framework for digital pathology analysis of whole slide images of preclinical animal studies. The framework includes specific functions to identify lesion type, severity, and location, it says.

“The initial application of the proposed PathologAI framework in necrotic-lesion identification is encouraging,” the statement says, “and the pinpointed lesion locations are consistent with the manual examinations by pathologists.”