A practical guide to validating a clinical NGS assay with real-world examples from leading clinical genomics experts.
This video shows how Directed Genomics and New England Biolabs use highly multiplexed reference materials during optimization and validation to fine-tune assay performance.
Multi-Laboratory Assessment of a New Reference Material for Quality Assurance of Circulating Tumor DNA Measurements
The accurate diagnosis and monitoring of cancer, using circulating tumor DNA, is a major challenge, given the low concentration and complexity of the target molecules.
Asuragen’s Associate Director of Bioinformatics explains how SeraCare’s ctDNA allows confident quantification of trace levels of ctDNA in their NGS-based assay.
UNC evaluated a test system that preferentially amplifies fragmented DNA to reduce impact of ex vivo release of cellular DNA, and that capitalizes on “unique molecular identifiers” and variable amplicon lengths to improve assay performance.
Drs. Greg Tsongalis and Russell Garlick review how to employ modern NGS QC tools to accelerate the development of your clinical genomics assay for less than it costs with traditional materials and methods.
A panel of clinical genomics experts provides an overview of the regulatory landscape for laboratory-developed tests. Panelists discuss how clinical genomics labs can and should ensure the analytical and clinical validity of their tests amid an uncertain regulatory climate.
Learn how highly multiplexed NGS reference materials can help you speed development, validate more robustly, and implement better clinical genomics assays. Find ways to streamline your lab’s processes to get your assay in production faster and keep your metrics on track.
Drs. Tony Godfrey, Peggy Gulley, and Greg Tsongalis provide expert perspectives on what it takes to achieve full clinical potential for ctDNA assays.
QC Case Study
This case study details how Navican built a best-in-class QC protocol. They discuss how and why they implemented SeraCare reference materials and iQ NGS QC Management software.
Dr. Bob Daber and Dr. Russell Garlick discuss real-world examples that illustrate how highly multiplexed, patient-like biosynthetic reference materials offer substantial time and cost advantages over traditional materials and methods.
Gregory J. Tsongalis of Dartmouth Hitchcock Medical Center discusses how his lab developed and validated a cancer hotspot assay.
Dr. Robert Daber discusses how labs can establish laboratory QC systems to comply with CAP, CLIA, and state regulatory guidelines.
Tony Godfrey of the Boston University School of Medicine discusses how his lab is developing and validating clinical circulating tumor DNA assays.
NGS QC Metrics
Francine Blumental de Abreu, PhD presents how a lab can measurably improve and simplify their validations and daily QC using powerful reference materials and lab QC software to track and report all key QC metrics.
Dr. Sandi Deans, Director of UK NEQAS for Molecular Genetics, presents a case study of how a global EQA organization ensures the accuracy and consistency of a clinical genomics application.
A protocol, developed in partnership with Thermo Fisher Scientific, that ensures a thorough and accurate assessment of your Ion Torrent Oncomine Myeloid Research Assay using the Seraseq Myeloid Reference Materials (RNA and DNA).
This report by clinical genomics experts focuses on the validation and implementation of clinical NGS assays. Find case studies as well as an overview of validation processes for laboratory-developed clinical genomics tests and specific validation guidelines.
This guide contains best practices to help you develop an NGS-based clinical genomics assay and bring it online as quickly and cost-effectively as possible. Overcome the top three assay development challenges faced by clinical laboratories.