CellCarta and Imagene AI Expand CRO Collaboration to Validate and Deploy AI-Powered Biomarker and CDx Programs With Leading Pharma Partners

• CellCarta, a leading global CRO laboratory to the biopharmaceutical industry, and Imagene AI, a precision oncology intelligence company, have announced an expanded collaboration to provide a coordinated path for biopharma companies to validate, deploy, and scale AI-powered biomarker and companion diagnostic programs — combining Imagene AI’s AI-powered assay development and biomarker prediction capabilities with CellCarta’s global CDx development infrastructure and regulatory expertise.

• The collaboration is already supporting active programs with two leading global pharmaceutical companies — including an AI-powered IHC companion diagnostic development program and a program applying Imagene AI’s Lung Prediction Panel in non-small cell lung cancer — and builds on Imagene AI’s participation in CellCarta’s Digital Pathology and AI Consortium announced in July 2026.

CellCarta, a leading global CRO laboratory to the biopharmaceutical industry, and Imagene AI, a precision oncology intelligence company delivering AI-powered pathology assays for biomarker discovery and companion diagnostic development, announced on October 1, 2026, from Montreal, Canada and Miami, Florida, an expanded collaboration to provide a coordinated CRO pathway for biopharma companies to validate, deploy, and scale AI-powered biomarker and CDx programs. The collaboration covers the full program arc from biomarker strategy and assay development through analytical validation, global clinical trial deployment, regulatory readiness, and commercialization.

The collaboration is already generating active program outputs with two leading global pharmaceutical companies. The first involves an AI-powered IHC companion diagnostic development program in which Imagene AI’s OI CDx capabilities — applying quantitative AI pathology to assess biomarker and target expression including cell and subcellular analysis, continuous and spatial scoring, and patient stratification — are being validated and deployed within CellCarta’s CDx development and global laboratory infrastructure. The second program applies Imagene AI’s Multi-gene Lung Prediction Panel in non-small cell lung cancer, using the panel’s ability to predict key NSCLC biomarkers directly from routine H&E whole-slide images within minutes as a practical patient identification tool embedded within the laboratory and clinical trial infrastructure required for broader clinical deployment. Additional details on both programs are expected to be disclosed in the coming months.

The operational model underpinning the collaboration is structured to close the gap that has historically separated AI-powered pathology innovation from regulatory-grade clinical deployment. Imagene AI contributes the AI assay development and biomarker prediction layer — including multimodal foundation models, real-world data infrastructure, and H&E-based molecular profiling capabilities — while CellCarta provides the fit-for-purpose analytical validation, CAP-accredited and CLIA-certified global laboratory operations across Canada, the U.S., Belgium, Australia, and China, CDx development expertise, and regulatory strategy required to advance AI-generated biomarker insights into sponsor-grade clinical trial evidence. For biopharma CRO clients, the model removes the need to separately source and coordinate an AI pathology technology partner and a CDx laboratory CRO — collapsing two vendor relationships into one coordinated program.

The expansion builds directly on Imagene AI’s founding membership in CellCarta’s Global Digital Pathology and AI Consortium, announced in July 2026, which brought seven AI and digital pathology technology partners into CellCarta’s laboratory infrastructure under an AI-agnostic operating model. The expanded bilateral collaboration moves beyond consortium membership into active co-delivery of biopharma programs — demonstrating how the consortium framework is designed to function in practice: AI technology partners contributing algorithms and prediction models; CellCarta contributing the validation, laboratory, and regulatory infrastructure that makes those models clinically and regulatorily actionable. CellCarta and Imagene AI will be presenting the expanded collaboration at the World CDx and CB Summit in Boston, Massachusetts, October 5–8, 2026.

“Bringing AI-powered approaches into global drug development requires more than a strong algorithm — it requires the ability to validate, deploy and scale within the rigor of clinical development. Our collaboration with Imagene AI combines their AI pathology capabilities with CellCarta’s global laboratory infrastructure, CDx development experience, and regulatory expertise to validate fit-for-purpose assays, deploy them in global clinical trials, and scale programs toward regulatory readiness and commercialization.”

Christopher Ung, Chief Scientific Business Officer, CellCarta