Build Your Own NGS Reference Standard: Try Our VariantFlex Configurator

NGS REFERENCE STANDARDS

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

INFECTIOUS DISEASE ASSAY TOOLS

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

IMMUNOASSAY REAGENTS

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

NGS CONTROLS FOR CANCER PROFILING ASSAYS

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

CLINICAL NGS RESOURCE CENTER

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

LOOKING FOR CLARITY ON NGS VALIDATION GUIDANCE?

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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TESTIMONIALS

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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

Cancer research is purposely methodical and measured. So – somewhat paradoxically – it can be difficult to keep up with the steady stream of discoveries in the literature and presented at conferences like AACR. As a developer and manufacturer of platform-agnostic NGS reference standards, we’re in a unique position to collaborate with cancer genomics assay developers, laboratories, pharmaceutical companies, and other organizations invested in more precise and robust cancer tests.

I am pleased to share findings from a newly published peer-reviewed study with foundational circulating tumor DNA (ctDNA) pre-analytical and analytical testing in multiple technologies and assay chemistries. The study, “Multi-laboratory Assessment of a New Reference Material for Quality Assurance of Cell-Free Tumor DNA Measurements,” was just published in The Journal of Molecular Diagnostics (He, Stein et al. 2019).

As originally seen in The Journal of Precision Medicine March 2019.

Targeted therapies and now recently, immunotherapies, have demonstrated great promise towards increasing response rates, as well as duration of response for cancer patients. This is often achieved by understanding biomarkers associated with therapeutic response and then stratifying patients accordingly.