CellCarta and Imagene AI expand CDx collaboration
The collaboration combines Imagene’s AI-powered assay development and biomarker prediction capabilities with CellCarta’s global companion diagnostics (CDx) and laboratory infrastructure, supporting active programs with leading pharma partners
2 Oct 2026
CellCarta and Imagene AI have announced an expanded collaboration to provide a coordinated path for biopharma companies to validate, deploy, and scale AI-powered biomarker and companion diagnostic (CDx) programs.
The collaboration is designed to support programs from biomarker strategy and assay development through 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 IHC companion diagnostic development program and a separate program applying Imagene AI’s Lung Prediction Panel in non-small cell lung cancer (NSCLC).
Within companion diagnostic development, Imagene AI’s OI CDx capabilities apply quantitative AI pathology to assess biomarker and target expression, including cell and subcellular analysis, continuous and spatial scoring, and patient stratification.
CellCarta enables biopharma sponsors to validate, deploy, and scale these AI-powered approaches combining fit-for-purpose analytical validation, global clinical-trial deployment infrastructure, companion diagnostic development capabilities, and regulatory expertise to advance programs from development through regulatory readiness and commercialization.
Imagene AI’s Multi-gene Lung Prediction Panel predicts key NSCLC biomarkers directly from routine H&E whole-slide images within minutes. The panel represents a practical use case for how Imagene AI and CellCarta can support biomarker-driven clinical trials, combining rapid H&E-based patient identification with the laboratory and clinical-trial infrastructure required for broader deployment.
“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,” said Michael Hreczuck, SVP of Business Development at Imagene AI.
“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.”
“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,” said Christopher Ung, Chief Scientific Business Officer, CellCarta.
“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.”
Lung Prediction Panel is for Research Use Only (RUO) and not for use in diagnostic procedures.
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How will CellCarta and Imagene AI support AI-powered biomarker and companion diagnostic programs?
Their expanded collaboration provides biopharma companies with a coordinated path spanning biomarker strategy, assay development, analytical validation, global clinical trial execution, regulatory readiness, deployment, and commercialization.
What role does Imagene AI’s Multi-gene Lung Prediction Panel play in NSCLC clinical trials?
The panel predicts key non-small cell lung cancer biomarkers from routine H&E whole-slide images within minutes. Combined with CellCarta’s laboratory and clinical trial infrastructure, it supports rapid patient identification and broader deployment in biomarker-driven trials.
How do Imagene AI and CellCarta advance AI-powered IHC companion diagnostic development?
Imagene AI’s OI CDx capabilities use quantitative AI pathology for biomarker and target-expression assessment, including cell and subcellular analysis, continuous and spatial scoring, and patient stratification. CellCarta adds fit-for-purpose validation, global deployment infrastructure, CDx development experience, and regulatory expertise.