CellCarta and Imagene AI Expand Collaboration to Validate, Deploy and Scale AI-Powered Biomarker and Companion Diagnostic Programs Across Drug Development

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.

MONTREAL and MIAMI, Oct. 1, 2026 /PRNewswire/ -- CellCarta and Imagene AI today 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). Additional details on these programs are expected to be disclosed in the coming months.

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.

The collaboration also extends to Imagene AI's Multi-gene Lung Prediction Panel, which 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."

The expanded collaboration builds on Imagene AI's participation in CellCarta's Digital Pathology and AI Consortium, announced in July 2026, and extends the companies' relationship into active biopharma development programs. Imagene AI and CellCarta will be available at the upcoming World CB and CDx Summit in Boston, MA on October 5-8 to discuss the expanded collaboration.

^{Lung Prediction Panel is for Research Use Only (RUO) and not for use in diagnostic procedures.}

About CellCarta

CellCarta is a leading global CRO laboratory to the biopharmaceutical industry. With CAP accreditations and CLIA certifications for specific testing methods and facilities in Canada, USA, Belgium, Australia, and China, CellCarta provides a wide range of biomarker testing services and customized solutions to world-renowned pharmaceutical companies. By integrating analytical platforms in immunology, histopathology, proteomics, and genomics, along with sample management and logistics services, CellCarta supports the entire drug development cycle from discovery to late-stage clinical trials. Visit cellcarta.com and connect with us on LinkedIn and X.

About Imagene AI

Imagene AI delivers precision Oncology Intelligence through robust multimodal foundation models and proprietary real-world data, accelerating biomarker discovery, patient stratification, response prediction, and companion diagnostic development. From H&E-based molecular profiling to AI-IHC companion diagnostics, Imagene AI develops AI-powered pathology assays that translate biological insight into patient selection and diagnostic strategies. Imagene AI collaborates with leading biopharma organizations to advance biomarker-driven programs from discovery through clinical development and deployment. For more information, visit https://imagene-ai.com/.

Media Contacts

Stéphanie Bussières-Marmen, PhD
Director, Global Marketing
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Melanie Williams
Senior Marketing Communications Specialist, Supreme Optimization
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Avital Rabani
Head of Corporate Marketing, Imagene AI
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SOURCE CellCarta