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.”
About Modella AI
Modella AI is a Boston-based biomedical AI company dedicated to advancing healthcare through the development of cutting-edge generative and agentic AI technologies. Its mission is to enhance diagnostic accuracy and access through intelligent, scalable platforms that empower healthcare providers. Visit www.modella.ai for more information.
About illumiSonics Inc.
illumiSonics Inc. is a biomedical technology company developing non-destructive, label-free imaging platforms for high-content tissue analysis. Its patented technology platform enables high-resolution optical sectioning and digital reconstruction of tissue architecture without the need for dyes, stains, or tissue damage—unlocking unprecedented flexibility for clinical diagnostics, research, and biopharmaceutical development. Learn more at www.illumisonics.com.
Disclaimer:
PathChat™ DX and the illumiSonics MLI™ platform are research-use only devices and are not commercially available outside of research use. The FDA Breakthrough Device Designation for PathChat DX does not imply FDA clearance or approval. This press release contains forward-looking statements based on current assumptions and forecasts. Modella AI and illumiSonics assume no obligation to update these statements to reflect future events or developments.
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“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