Precision Immunohistochemistry (IHC) Services for Biomarker Development and CDx Success

Expression patterns across tissues at all developmental stages

Faster, More Reliable IHC with Discovery’s Experts

Our IHC services are led by the scientists behind the development of low‑HER2 and PD‑L1 CDx assays, delivering precise and actionable insights for biomarker development, therapeutic target validation, and prevalence studies from preclinical research through CDx development.

Expert‑Driven Insights from Preclinical to CDx

Expertise

Decades of experience developing, validating and applying IHC assays throughout every stage of development for leading biotech and pharma clients.

Technology

A technology agnostic approach to enable an unbiased selection of the most suitable platforms.

Compliance & Quality

Specialty testing in CLIA-certified, CAP accredited, and GCLP compliant service laboratories to support concurrent clinical trials and regulatory submissions. IVDR-compliant services with Health Institution status of Discovery’s laboratory in Germany confirmed by German Regional Council.

Global Harmonization

Global standardization and harmonization of IHC assays including global clinical trial testing and our Biomarker Academy™ training programs with post-approval services.

Access to Clinical Specimens

Access to the world’s largest commercial biorepository to build optimal study cohorts.

Rapid Orthogonal Testing

Optimized multi-omic integration with clinical flow, cell biology, genomic, and proteomic services – all under one roof.

Technology Platforms

We use a technology-agnostic approach so you can choose the right technology for your project. Our expert scientists work with you consultatively to make sure your study is designed to achieve optimal outcomes.

Digital Pathology / Scanners / Image Analysis

IHC / Multiplex IF /
ISH

A Smarter, Proven Path to Successful Validation

Our experts have designed an industry-leading assay validation approach that starts with careful IHC assay development and optimization. We do more than simply demonstrate that an assay can detect a target in various conditions, we:

Applications

Immunohistochemistry Services Frequently Asked Questions

End-to-End IHC Workflow

Helping you understand your target biomarkers at every stage of research and clinical development using any leading technology platform.

Study & Biomarker Strategy

Clarity Before You Start

We align on study goals, timelines, and biological context, including mechanism of action, target biomarkers, and intended use. Our team helps define the right tissues, indications, and controls, and identifies optimal antibodies to support confident downstream analysis.

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IHC Assay Development & Optimization

Validated for Performance and Reproducibility

We optimize pretreatment conditions, confirm assay specificity, and evaluate sensitivity, range, and linearity. Scoring approaches are developed and validated to ensure robust, reproducible results aligned with applicable GCLP expectations.

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Study Execution & Quantitative Analysis

Consistent Results at Research or Clinical Scale

We perform IHC testing on research or clinical samples using validated methods and scoring criteria. Expression patterns, tumor surveys, and cutoff thresholds are generated to support biomarker prevalence assessment and patient stratification.

Integrated labs maintain chain-of-custody and accelerate EU trial startup.

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Pathology Review & Study-Ready Reporting

Insights You Can Act On

Full-service pathology review and customized reporting translate staining data into meaningful biological insight. Outputs are delivered in study- and submission-ready formats, with support for IND-enabling programs and Prototype CDx planning.

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