Modella AI, a leader in generative and agentic artificial intelligence for biomedicine, and illumiSonics Inc., a leader in label-free optical imaging and computational pathology, today announced successful research demonstrating compatibility between illumiSonics’ research-use only Multi-Laser Imaging (MLI™) system and Modella AI’s research-use only PathChat™ DX platform, which has been granted a Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). These novel study findings support the potential of an end-to-end, fully digital pathology workflow—from label-free tissue imaging to AI-enabled diagnostic interpretation—conducted without chemical staining or tissue damage.
In the joint study, the illumiSonics’ MLI system produced virtual H&E (Hematoxylin and Eosin-like) images from unstained skin tissue resections showing various malignant features. These de-identified images were analyzed using the PathChat DX platform, which had no prior exposure or training on any form of virtual histology. Diagnostic interpretations from the PathChat DX platform were compared to consensus reads by eight board-certified pathologists with expertise in dermatologic pathology who reviewed both the virtual images and matched chemical H&E slides. Concordance between PathChat DX and expert pathologists was extremely high, demonstrating the feasibility of a fully digital, AI-assisted workflow from unstained whole slides to clinical diagnosis.
“Enabling diagnostic-grade AI inference from label-free slides is a transformative step forward and advances the vision of digital-first pathology workflows that preserve tissue integrity and can streamline diagnostic throughput,” said Jill Stefanelli, CEO of Modella AI. “While PathChat DX remains research-use only, its compatibility with diverse imaging outputs like those from the MLI™ platform reinforces the adaptability and promise of our generative and agentic AI platform.”
Results of this novel research study underscore the advantages of label-free imaging over chemical staining that is used in traditional pathology workflows, which is irreversible, labor-intensive, and can interfere with downstream molecular testing. illumiSonics’ MLI platform produces high-resolution virtual H&E images without dyes or tissue destruction, highlighting its potential value in clinical settings that prioritize tissue preservation for additional molecular testing. and precision medicine applications.
“illumiSonics is proud to collaborate on research that explores new possibilities for stain-free, digital pathology,” said John Mackey, CEO of illumiSonics Inc. “Our MLI system is designed to generate morphologically rich, label-free images suitable for computational analysis in research environments. This compatibility study with PathChat DX demonstrates the potential for next-generation virtual histology to drive fully automated diagnostic pipelines, unlocking new possibilities in clinical diagnosis, precision medicine, and translational research.”