CDx
Services
AI-powered companion
diagnostic co-
development
One coordinated partnership
across the CDx lifecycle
Quantitative IHC analysis Segmentation • Spatial biomarker scoring • Cohort analysis
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Clinical-grade AI assay development -
Trial enablement -
Regulatory & deployment support
One coordinated partnership across the CDx lifecycle
Imagene supports companion diagnostic co-development programs from biomarker strategy and quantitative AI assay development through validation, regulatory and reimbursement planning, and scalable deployment across partnered laboratory and CRO workflows.
From Biomarker Discovery to Commercial Launch
Imagene involvement can be tailored by program stage. Pharma partner and CRO responsibilities are based on clinical and regulatory requirements, which are aligned on during contracting.
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Biomarker Discovery & Candidate Selection -
Translational Development -
Trial Assay Development -
Patient Selection Strategy -
Pivotal Clinical Validation -
Regulatory Submission & Launch
Collaboration in Action:
Featured Collaboration
Advancing Biomarker
Driven Oncology
Imagene and Daiichi Sankyo are collaborating on multimodal biomarker
discovery and response prediction modeling, including quantitative IHC scoring for select ADC development programs under development.
- Multimodal biomarker discovery
- Response prediction modeling
- Composite continuous scoring for IHC
Partnering with Preferred Providers Worldwide
Clinical Translation
in Practice
Experience Translating Pathology AI into Clinical Laboratory LDT Use
LungOI is a Laboratory Developed Test (LDT) that demonstrates Imagene's ability to translate an AI-powered pathology assay into an operational, reimbursed clinical workflow.
Among pathology image–based AI assays, LungOI is a LDT that is part of an early class to achieve the commercialization infrastructure required for US clinical use, including a dedicated PLA code, CLIA/CAP laboratory deployment and CMS-established payment.
- Laboratory developed test
- Dedicated PLA code 0414U
- CLIA-certified and CAP-accredited laboratory
- CMS-established reimbursement rate of $706
- Commercially available as a LDT
- Detects eight oncology biomarkers
with confirmatory molecular test
LungOI is performed as a laboratory developed test in a CLIA-certified, CAP-accredited laboratory and has not been cleared or approved by the United States Food and Drug Administration (FDA).
Imagene maintains ISO 13485, is certified for both ISO/IEC 27001 and ISO 27799, and is compliant with HIPAA and GDPR regulations.
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Developing intended use and regulatory
pathway planning -
Submission documentation and agency interaction support -
Analytical and clinical validation strategy -
Assay lock, transfer, change control,
and lifecycle planning
Regulatory and
Development Capabilities
to Support CDx
Co-development
Cross-functional experience across assay development, quality systems, regulatory planning, laboratory deployment, and reimbursement
Differentiated IHC Capabilities
In addition to continuous staining quantification, H-scoring, and cell type identification, Imagene offers the following advanced features:
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High-definition cell and subcellular segmentation including adaptive-width membrane segmentation -
AI tools to identify meaningful feature combinations that could potentially differentiate clinical populations -
Novel spatial biomarker score to potentially use for prediction of drug responses -
Unique stratification tools for analysis of patient populations
Advance your program with a partner experienced from discovery through deployment.
Tell us about your program stage and next milestone. We'll help identify a practical path forward.
OI CDx is a co-development services offering. Regulatory authorization and reimbursement will be pursued in partnership with Pharma.