PhenoMATRIX is an in vitro diagnostic software that uses artificial intelligence with laboratory-defined rules and clinical information to automatically sort images of bacterial culture plates, helping laboratory professionals streamline plate review while maintaining expert oversight.

The cleared intended use includes blood-based, chocolate and MacConkey agars, as well as CHROMagar orientation culture media plates, enabling semi-quantitative and qualitative image-based analysis through detection of microbial growth, estimation of colony counts, and differentiation of isolates based on phenotypic colony characteristics.

“This clearance represents a major milestone for Copan and microbiology laboratories in the United States,” said Fabrizio Mazzocchi, CEO of Copan Diagnostics. “PhenoMATRIX builds on years of scientific development and real-world data to support laboratories and the critical work they do in patient care.”