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White Papers and Videos

Next-Generation Sequencing Assay Validation A Practical Guide for the Clinical Genomics Laboratory (updated eBook)

White Paper

Next-generation sequencing (NGS) has revolutionized the field of genomics and how in vitro diagnostic (IVD) test developers, laboratories, and clinicians are diagnosing, treating, and monitoring disease. Before you can successfully launch a clinical assay, platform, or service, you need to be absolutely confident that the test has gone through rigorous development and thorough validation to ensure accuracy of the result.

This eBook focuses on the validation process for NGS-based assays and will walk through key considerations and guidelines you can follow to ensure a smooth and successful validation.

Trends in Clinical NGS QC Management: Results from a Practitioner Survey

White Paper

A Genomeweb/SeraCare NGS QC Survey Report:

This report outlines the results of a survey that sought to understand quality control management practices in clinical next-generation sequencing labs.

By focusing on how clinical NGS labs determine QC stops; the impact of QC stops on reporting results, lab productivity, and reimbursement; and the use of tools such as reference materials and data management solutions, our goal with this survey was gain greater insight into the QC habits and best practices of the clinical NGS community worldwide.

A Practical Guide to Clinical Genomics Assay Validation: Webinar On Demand

Video

This webinar walks through key considerations and helpful guidelines to accelerate next-generation sequencing (NGS)-based clinical genomics assay validation for less money and greater confidence in results.

NGS has revolutionized how assay developers, laboratories, and clinicians are diagnosing, treating, and managing disease. But before a clinical genomics assay can help guide patient care, it must be thoroughly validated. While validation principles are universal, the complexities of NGS can make the process a daunting task. In this webinar, clinical genomics expert Dr. Bob Daber uses real-world examples to highlight how highly multiplexed, patient-like biosynthetic reference materials offer substantial time and cost advantages over traditional materials and methods.


View this webinar to learn:

  • 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

Next-Generation Sequencing Assay Validation: A Practical Guide for the Clinical Genomics Laboratory

White Paper

Next-generation sequencing (NGS) has revolutionized the field of genomics and how in vitro diagnostic (IVD) test developers, laboratories, and clinicians are diagnosing, treating, and monitoring disease. Before you can successfully launch a clinical assay, platform, or service, you need to be absolutely confident that the test has gone through rigorous development and thorough validation to ensure accuracy of the result.

How to Develop a Clinical NGS Assay Without Losing Your Mind or Your Shirt

White Paper

A genomics revolution has been underway for nearly a decade, and clinical laboratories are the catalyst.

An exponentially growing body of clinical evidence shows doctors can diagnose and treat some of the most deadly and persistent forms of cancer by looking to the genome. And as the new world of pathway-based therapeutics intersects with faster and cheaper DNA/RNA sequencing technologies, physicians, researchers, and patients are turning toward molecular pathology laboratories to lead the
way.

You want to expand your use of the new diagnostic tools for your patient population. And to do so, you need to develop clinical NGS-based assays and bring them online as quickly and cost-effectively as possible.

"Patient-Like Circulating Tumor DNA Reference Materials for Evaluation of Next-Generation Sequencing Tests"

White Paper

Clinical oncologists are relying on analysis of circulating tumor DNA (ctDNA) across an increasing number of applications.

While highly sensitive methods such as NGS and digital PCR may yield vital information, performance of ctDNA tests must be thoroughly understood to ensure fidelity of patient results.

Download this poster to see how our purpose-built ctDNA reference material has greatly improved patient-like properties compared to materials produced by sonication alone, and may be effectively used to evaluate assay performance.

NGS-based Assay Validation and QC: A Solution for the Clinical Sequencing Lab

Video

In this recording, Francine Blumental de Abreu, Assistant Director Laboratory for Clinical Genomics and Advanced Technology (CGAT) at Dartmouth Hitchcock Medical Center, discusses how a lab can measurably improve and simplify its validation and daily QC using powerful reference materials, while also implementing easy-to-use lab QC software to track and report all key QC metrics.