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CellCarta and Imagene AI Scale AI-Driven Companion Diagnostics

CellCarta and Imagene AI Scale AI-Driven Companion Diagnostics

By integrating Imagene’s AI pathology models with CellCarta’s global laboratory infrastructure, the two companies are creating a standardized pathway for pharmaceutical firms to validate and deploy biomarker-based diagnostic programs, moving beyond experimental algorithms into the rigorous demands of large-scale clinical trials and regulatory approval.

The partnership focuses on bridging the gap between digital pathology innovation and clinical execution. Currently, the firms are jointly developing an AI-powered immunohistochemistry (IHC) diagnostic and applying Imagene’s Lung Prediction Panel to identify biomarkers in non-small cell lung cancer (NSCLC) cases. These efforts allow sponsors to analyze tissue samples using spatial scoring and subcellular analysis, then scale those methodologies across international trial sites.

Michael Hreczuck, SVP of Business Development at Imagene AI, noted that pharma partners require a practical bridge to translate digital insights into validated assays. Christopher Ung, Chief Scientific Business Officer at CellCarta, added that the collaboration provides the necessary regulatory expertise and infrastructure to move AI tools from the research phase into commercialization. The companies plan to discuss these ongoing projects at the upcoming World CB and CDx Summit in Boston, building upon their existing work within CellCarta’s Digital Pathology and AI Consortium.

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