Expanded Partnership Supports AI Biomarker Validation and Clinical Trial Deployment

CellCarta (Montreal, Canada) and Imagene AI (Miami, FL, USA) have expanded their collaboration to provide biopharma companies with a coordinated pathway for biomarker strategy, assay development, validation, clinical trial execution, regulatory readiness, and deployment. The companies are currently working together on programs with two leading global pharmaceutical companies. These include an AI-powered immunohistochemistry companion diagnostic development program and a separate program applying Imagene AI’s Lung Prediction Panel in non-small cell lung cancer.

Imagene AI’s OI CDx capabilities apply quantitative AI pathology to assess biomarker and target expression. The approach includes cell and subcellular analysis, continuous and spatial scoring, and patient stratification. The collaboration also includes Imagene AI’s Multi-gene Lung Prediction Panel, which predicts key non-small cell lung cancer biomarkers directly from routine hematoxylin and eosin whole-slide images within minutes.

CellCarta supports these AI-powered approaches through analytical validation, global clinical trial deployment infrastructure, companion diagnostic development capabilities, and regulatory expertise. The Lung Prediction Panel is for Research Use Only and is not for use in diagnostic procedures. The expanded collaboration builds on Imagene AI’s participation in CellCarta’s Digital Pathology and AI Consortium, announced in July 2026, and extends the relationship into active biopharma development programs.

“Pharma companies need a practical path for translating AI-powered biomarker and image-analysis capabilities into assays that can support clinical development and companion diagnostic programs. We are pleased to join forces with CellCarta, a leader in clinical biomarker and companion diagnostic development, to support programs from assay development through commercialization. We are already applying this model across active pharma programs in both AI-powered IHC and H&E-based biomarker prediction,” said Michael Hreczuck, SVP of Business Development at Imagene AI.

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