Build Your Own NGS Reference Standard: Try Our VariantFlex Configurator


Widest selection of high-performance multiplexed clinical genomics reference standards for tumor profiling, NIPT, cell-free DNA, and germline sequencing applications


Globally recognized serological and molecular quality controls and panels to validate, monitor, and ensure confidence in assay performance


Readily available antibodies and immunoassay reagents to accelerate research and IVD assay development

Assay Developer OEM Solutions

Test Tube

SeraCare helps leading diagnostic assay developers build more robust assays, more quickly, with an array of highly customizable biological materials


SeraCare offers the broadest selection of reference materials with clinically relevant DNA and RNA variants applicable for NGS and PCR-based tests


Access helpful articles, white papers, and customer case studies on how to use SeraCare clinical genomics tools for validating and operationalizing your clinical assays

Validation eBook Cover


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

Download Our NGS Validation eBook


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  • 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

Our Latest Blogs


Of the many fantastic posters presented at AMP’s Annual Meeting in San Antonio, two concerning NGS-based liquid biopsy assays stood out. Both presenters described how their organizations are working to reliably detect pathogenic variants at extremely low allele frequencies – efforts critical to the clinical adoption of NGS-based liquid biopsy assays.

Figure 1 Frustrated Actor in PocketHose Infomercial

Have you ever seen those late night infomercials? One of the things I love whenever I have watched these is the over-the-top acting to depict whatever frustration the target audience must be feeling if they can’t coil up their garden hose or manage their closet space.

As frustrated as these actors are, I can’t help but imagine what an actor’s depiction of the level of frustration that a clinical genomics lab director might be feeling when things don’t go according to plan while carrying out an NGS assay.

Figure 1 Frustrated Actor in PocketHose Infomercial

SeraCare’s clinical genomics technologies are developed to address challenges faced across the spectrum of NGS assays. From early development of assays – either IVD assay manufacturers or clinical labs building their own LDTs - there is a scarcity of characterized, complex, difficult variants to ensure the assay can robustly detect all the critical genomic variants in a patient sample. Using our highly characterized, reproducible, and GMP-grade NGS standards, laboratories have a wide range of analytical and clinical validation tools to deeply characterize assay performance such as LOD, linearity, specificity, sensitivity, and reproducibility.