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Assay Development
and Validation

Accelerate assay development and validation with our expertise and technology in every stage of development, and Health Institution status for IVDR programs.

By choosing Discovery for assay development and validation, you’ll get a single partner that provides:

Customization & Flexibility

Experts work directly with you to customize and optimize every project and ensure your needs are met


Decades of experience developing and validating companion diagnostics for leading biotech and pharma clients


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

Health Institution Status

IVDR development with Health Institution status of Discovery's laboratory confirmed by German Regional Council


One of the largest commercial fleets of proteomics, genomics, and molecular pathology instruments – all under one roof

Global Training and Harmonization

Global standardization and harmonization of IHC assays via our Biomarker Academy™ training programs and post-approval services

Clinical Specimens

Direct access to the world’s largest commercial biorepository

Fit-for-Purpose Validation

Our Scientists will work with you to develop the right validation for each of your projects.

Assay Development

Our experts develop assays, focusing on the desired outcome, to ensure precise targeting of the right patients on the right platforms.  We use our large biorepository, advanced laboratory technologies, and integrated multi-omic workflows to help you understand biomarker expression and assay performance across disease indications.

Assay Validation

We expertly measure and optimize assay performance to deliver robust assays that help accelerate your program from RUO to LDT and IVDR. We have experience validating hundreds of assays and routinely providing services spanning biomarker discovery to regulatory submission.

Technology Platforms

Discovery takes a technology-agnostic approach to enable an unbiased selection of the most suitable platforms and technologies for developing and validating diagnostic assays. This approach ensures optimal performance and accuracy, flexibility, adaptability, and the ability to leverage advancements in different technologies, leading to improved assay development and broader applicability.



Flow Cytometry

Molecular Pathology

Case Studies

Genomics Validation – TruSight Oncology

Demonstration of the accuracy, sensitivity, and reproducibility of our TSO500 ctDNA NGS service Read Tech Note

Molecular Pathology Validation

How we validate IHC assays measuring sensitivity, specificity, stability and reproducibility Download Case Study

Development of the Prototype IHC CDx Assay that Advanced Development of Pembrolizumab

Discovery developed an assay with dynamic range, high precision and reproducibility, laying the foundation for the successful 22C3 PD-L1 companion diagnostic assay widely utilized today. Download Case Study

Establishing HER2 as a Companion Diagnostic Biomarker for the Treatment of Breast & Gastric Cancers

Discovery has been instrumental in helping determine HER2 assay design, evaluation, scoring, and clinical utility for use in breast, esophageal and gastric cancers. Download Case Study

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Development and Clinical
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