CellCarta, Imagene AI Broaden Ties on AI Biomarkers, Companion Diagnostics

CellCarta and Imagene AI announced an expanded collaboration on October 1, 2026, to provide biopharma companies a coordinated path for validating, deploying and scaling AI-powered biomarker and companion diagnostic (CDx) programs, and said work is already underway with two global pharmaceutical companies.

The expanded collaboration is meant to carry programs from biomarker strategy and assay development through validation, clinical trial execution, regulatory readiness and deployment, the companies said in the announcement published by CellCarta, issued from Montreal and Miami. It combines Imagene AI’s AI-powered assay development and biomarker prediction capabilities with CellCarta’s global companion diagnostics and laboratory infrastructure.

Active Pharmaceutical Programs

The companies said they are currently working together on programs with two pharmaceutical companies they describe as leading global firms. One is an AI-powered immunohistochemistry (IHC) companion diagnostic development program; the other applies 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, the companies said.

Within companion diagnostic development, Imagene AI’s OI CDx capabilities apply quantitative AI pathology to the assessment of biomarker and target expression, spanning cell and subcellular analysis, continuous and spatial scoring, and patient stratification, according to the announcement. CellCarta’s contribution combines fit-for-purpose analytical validation, global clinical-trial deployment infrastructure, companion diagnostic development capabilities and regulatory expertise, which the companies describe as a path to advance programs from development through regulatory readiness and commercialization.

Multi-Gene Lung Prediction Panel

The collaboration also extends to Imagene AI’s Multi-gene Lung Prediction Panel, which the companies describe as predicting key NSCLC biomarkers directly from routine hematoxylin-and-eosin (H&E) whole-slide images within minutes. According to the announcement, the panel shows how the two companies can support biomarker-driven clinical trials by pairing rapid H&E-based patient identification with the laboratory and clinical-trial infrastructure needed for broader deployment.

The Lung Prediction Panel is designated for Research Use Only (RUO) and is not for use in diagnostic procedures.

Michael Hreczuck, SVP of Business Development at Imagene AI, said pharmaceutical 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, adding that the company is joining CellCarta 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,” he said.

Christopher Ung, Chief Scientific Business Officer at CellCarta, said bringing AI-powered approaches into global drug development requires the ability to validate, deploy and scale within the rigor of clinical development, extending beyond the strength of an algorithm alone. He said the collaboration pairs Imagene AI’s 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.

Digital Pathology and AI Consortium

The expanded collaboration builds on Imagene AI’s participation in CellCarta’s Digital Pathology and AI Consortium, announced in July 2026. CellCarta launched the consortium on July 15, 2026, initially bringing together Lunit, Mindpeak, Imagene AI, Dipath AI, Nucleai, Tivenix and Indica Labs alongside CellCarta’s histopathology, genomics, immunology, proteomics, sample logistics, data analysis and regulatory capabilities, according to the launch announcement.

CellCarta described the consortium as a non-exclusive, modular and AI-agnostic ecosystem designed to help biopharma sponsors accelerate biomarker discovery, patient stratification, clinical trial execution and companion diagnostic strategy across oncology, autoimmune, Alzheimer’s disease and other indications. In the July announcement, CellCarta characterized Imagene AI as delivering what it calls precision Oncology Intelligence through multimodal foundation models and proprietary real-world data, spanning biomarker discovery, patient stratification, response prediction and companion diagnostic development.

CellCarta said the consortium will support sponsor needs across exploratory biomarker discovery, image analysis, tumor microenvironment characterization, spatial biology, patient stratification, assay development, digital and AI-enabled companion diagnostic strategies, and retrospective or prospective clinical trial applications. Ung said at the launch that sponsors need a scientifically credible, operationally controlled way to evaluate, validate and deploy the right AI approach for the right program. Ehab A. El-Gabry, CellCarta’s Chief Medical Officer and Head of Companion Diagnostics, said digital pathology and AI are becoming central to the next generation of biomarker development and patient selection, framing the opportunity as making tissue, images and multi-omic data more quantitative, reproducible and actionable. CellCarta said it expects the consortium to evolve and expand over time as new technologies mature, additional disease areas emerge and sponsors require more integrated approaches.

Imagene AI and CellCarta will be available at the World CB and CDx Summit in Boston, Massachusetts, on October 5–8, 2026, to discuss the expanded collaboration.