Modella AI and illumiSonics Achieve Key Compatibility in Label-Free Digital Pathology Workflow

Modella AI and illumiSonics Inc. have announced a breakthrough in their collaboration, demonstrating successful compatibility between illumiSonics’ label-free optical imaging technology and Modella AI’s generative AI-powered pathology diagnostic platform. The partnership, which combines illumiSonics’ Multi-Laser Imaging (MLI™) system with Modella AI’s PathChat™ DX platform—a tool granted a Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA)—marks a significant step toward fully digital, non-invasive pathology workflows. In a joint study, illumiSonics’ MLI system generated high-resolution virtual Hematoxylin and Eosin (H&E)-like images from unstained skin tissue samples, capturing features of malignancies. These images were analyzed by PathChat DX, which had no prior training on virtual histology data. The AI platform’s diagnostic interpretations were compared to consensus readings by eight board-certified dermatopathologists who reviewed both the virtual images and traditional chemically stained H&E slides. The results showed exceptional agreement between the AI’s findings and those of human experts, validating the potential of a seamless, digital-first approach to pathology. “This compatibility represents a transformative leap for digital pathology, enabling diagnostic-grade AI analysis without compromising tissue integrity or requiring chemical stains,” said Jill Stefanelli, CEO of Modella AI. She emphasized that PathChat DX, though still research-use only, could adapt to diverse imaging formats like those produced by illumiSonics’ MLI system, highlighting its scalability and potential to revolutionize diagnostic processes. The study underscores the advantages of label-free imaging over conventional methods, which involve irreversible chemical staining, time-consuming preparation, and limitations in molecular testing. illumiSonics’ MLI platform generates detailed, morphologically accurate images without dyes or tissue damage, offering flexibility for downstream analyses like precision medicine and biopharmaceutical research. John Mackey, CEO of illumiSonics, noted the collaboration’s significance: “Our MLI system creates high-quality, stain-free images ideal for computational analysis. Partnering with Modella AI’s PathChat DX demonstrates how virtual histology can enable fully automated diagnostic pipelines, opening new avenues in clinical diagnostics, precision medicine, and research.” Modella AI, based in Boston, specializes in generative and agentic AI technologies for biomedicine, aiming to improve diagnostic accuracy and accessibility. illumiSonics, headquartered in Waterloo, Ontario, develops non-invasive imaging solutions for tissue analysis, leveraging its patented technology to digitally reconstruct tissue architecture without dyes or physical alteration. The research highlights a growing trend in AI-driven pathology, where digital workflows reduce reliance on traditional staining methods. By eliminating chemical reagents, the approach preserves tissue for further molecular testing, aligning with the needs of modern healthcare. However, both platforms remain research-use only, and the FDA’s Breakthrough Device Designation for PathChat DX does not equate to approval. The collaboration reflects the increasing convergence of AI and biomedical imaging, as companies seek to address inefficiencies in diagnostic workflows. With the MLI system’s ability to produce stain-free images and PathChat DX’s AI-driven analysis, the partnership could streamline pathology processes, reduce costs, and improve patient outcomes. Both firms stress that the study reinforces the viability of their technologies in advancing digital pathology. While commercial availability is pending, the results signal a shift toward more efficient, tissue-preserving diagnostic methods. The findings also align with broader industry efforts to integrate AI into healthcare, where data quality and accessibility are critical. The research underscores the potential for label-free imaging to become a cornerstone of future diagnostics, enabling faster, more accurate analysis while supporting advanced molecular studies. As AI and imaging technologies evolve, such partnerships may redefine how pathologists approach complex cases, blending innovation with clinical rigor.