Next-generation sequencing (NGS) has revolutionized how assay developers, laboratories, and clinicians are diagnosing, treating, and monitoring disease. As NGS panels grow to include an increasing number of important biomarkers, so too must the reference standards used for development, validation, and routine QC.
Next-Generation Sequencing Assay Validation: A Practical Guide for the Clinical Genomics Laboratory
This practical guide walks through key considerations and guidelines to help you accelerate NGS assay validation for less money and greater confidence in results. Learn about:
- Specific ways you can save time and money while thoroughly validating an NGS-based clinical genomics assay
- Validation best practices from leading clinical genomics laboratories
- How to navigate the many guidelines and requirements of the various authoritative bodies for clinical genomics testing
SeraCare have been fantastic in helping us develop the plasma-based EQA schemes. Technically, that's very challenging to deliver as an EQA provider; it's not an easy sample type to be able to just get on-tap from any patient or biobank.- Dr. Sandi Deans, Director, UK NEQAS for Molecular Genetics and Molecular Pathology
We're basically getting more bang for our buck from [Seraseq] reference materials because they have more mutations represented within them.- Dr. Brian Haynes, Associate Director of Bioinformatics, Asuragen
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Labs that demonstrate best practice clinical next-generation sequencing (NGS) quality management programs utilize positive run controls, designed for this purpose, to monitor assay analytical performance across each step of the clinical NGS workflow. Common parameters for assessing the analytical performance of a clinical NGS run include sensitivity (true positives), specificity (true negatives),
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