NGS reference materials are highly characterised materials used to assess, verify and validate sequencing assay performance. By providing known genomic targets, variant classes and defined variant allele frequencies (VAFs) or copy number levels, they support analytical sensitivity, specificity, accuracy, precision and limit of detection (LOD) studies. Unlike patient specimens, highly multiplexed reference materials provide renewable, lot-consistent sources of orthogonally validated variants for assay development, validation, verification and performance monitoring across clinical genomics workflows.
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Clinical genomics reference materials for NGS validation and performance verification
Highly characterised materials for sequencing assay performance assessment
Supporting the complete NGS assay lifecycle
Through the Seraseq® portfolio, LGC Clinical Diagnostics supports assay development, analytical validation, verification, assay harmonisation and routine performance monitoring using highly multiplexed DNA, RNA and ctDNA reference materials. Manufactured in ISO 13485-certified, cGMP-compliant facilities, these materials provide lot-to-lot consistency and reproducible performance across oncology, liquid biopsy, immuno-oncology and reproductive health workflows.
Who we support
NGS assay developers, molecular pathology laboratories, translational genomics teams, clinical bioinformaticians, laboratory directors, quality managers, IVD manufacturers, companion diagnostic developers, pharmaceutical companies and CROs conducting biomarker-driven clinical studies.
What they need
Defined VAFs and tumour fractions, orthogonally validated variants, comprehensive coverage across SNVs, INDELs, CNVs, structural variants and RNA fusions, dPCR-quantified targets, highly multiplexed mutation content, reliable materials for analytical sensitivity and LOD studies, and reproducible performance across platforms, operators and testing sites.
How clinical genomics reference materials support molecular diagnostics
Applications
Support assay development, analytical validation, verification and ongoing performance monitoring for precision oncology, liquid biopsy and molecular diagnostics workflows.
Technologies
Reference materials designed for dPCR, ddPCR, NGS and RNA sequencing workflows requiring accurate variant quantification and verification.
Featured Resources
Featured Resources
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Technical advantages of Seraseq® clinical genomics reference materials
Highly multiplexed, dPCR-quantified and NGS-validated reference materials for complex molecular workflows
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Global impact
37,000+
Customers supported worldwide
Reach
144
Countries served globally
Frequently asked questions
What are NGS reference materials?
NGS reference materials are highly characterised materials containing known genomic variants, copy number alterations, structural variants, RNA fusions or genomic signatures at defined concentrations or allele frequencies. They are used to assess analytical performance characteristics including sensitivity, specificity, accuracy, precision, reproducibility and limits of detection across NGS workflows.
Why are reference materials important for clinical genomics?
Reference materials provide known variant content and defined performance characteristics that help laboratories conduct assay validation, verification and ongoing performance monitoring.
How are reference materials used during validation?
They are commonly used for accuracy studies, precision studies, LOD determination, reproducibility assessments and workflow verification across multiple operators, instruments and sites.
What is variant allele frequency (VAF)?
Variant allele frequency represents the proportion of DNA molecules carrying a specific variant relative to the total DNA population within a sample.
Why are multiple VAF levels important?
Multiple VAF levels help laboratories assess analytical sensitivity and understand assay performance across clinically relevant reporting thresholds.
What is commutability?
Commutability describes how closely a reference material behaves like a patient specimen when analysed across different analytical methods and platforms.
How do Seraseq® reference materials support regulatory activities?
Each lot is supplied with documented target values and supporting analytical characterisation data that can be used during assay development, validation and verification activities.
Where can I obtain a Certificate of Analysis?
Certificates of Analysis are available through the documentation provided for each reference material lot.
What is the difference between a reference material and a certified reference material (CRM)?
A reference material is a characterised material used to assess analytical performance. A certified reference material (CRM) includes certified property values, measurement uncertainty and metrological traceability, making it suitable for calibration, method comparison and traceability studies.
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Need support with NGS assay development and validation?
Whether you are developing a comprehensive genomic profiling assay, validating a liquid biopsy workflow, establishing analytical sensitivity or supporting multi-site testing programmes, our specialists can help identify the most appropriate Seraseq® reference materials for your application.