A software program with image analysis algorithms [e.g., artificial intelligence (AI)-based] intended to be used in a digital pathology laboratory to assist in the analysis of stained or unstained clinical specimens (e.g., biopsy, cytology or blood smear on a microscope slide) for the quantitative and/or qualitative detection of cell markers (e.g., hormone receptors), changes in tissue architecture and/or cell morphological/physiological characteristics [e.g., nucleus size, cytoplasmic granularity, rate of cell division], and/or infectious microorganisms associated with a disease or condition (e.g., breast cancer, malaria). Results are interpreted by a clinician to guide patient management.