NGS Resources
Validation eBook
Next-Generation Sequencing Assay Validation Guide
A practical guide to validating a clinical NGS assay with real-world examples from leading clinical genomics experts.
NGS Validation
Reliable Interpretation of NGS Data Using Highly-Multiplexed Reference Material
This video shows how Directed Genomics and New England Biolabs use highly multiplexed reference materials during optimization and validation to fine-tune assay performance.
ctDNA
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.
Liquid Biopsy
An Efficient and Ultrasensitive NGS Solution for Profiling ctDNA
Asuragen’s Associate Director of Bioinformatics explains how SeraCare’s ctDNA allows confident quantification of trace levels of ctDNA in their NGS-based assay.
Cancer
Plasma Mutation Spectrum Matches Known Tumor Mutations in Active Cancer Patients
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.
NGS Validation
Validate Your Clinical Genomics Assay Without Crushing Your Budget or Sanity
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.
NGS Implementation
Best Practices for Validation, Monitoring, and Controls
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.
NGS QC
Finally, Reliable Quality Control for NGS Labs
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.
Liquid Biopsy
Expert Perspectives on Liquid Biopsy Clinical Implementations
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
Case Study: Using Robust QC to Improve Cancer Care
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.
NGS Validation
A Practical Guide to Clinical Genomics Assay Validation
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.
Case Study
Development and Validation of a Cancer Hotspot Assay
Gregory J. Tsongalis of Dartmouth Hitchcock Medical Center discusses how his lab developed and validated a cancer hotspot assay.
NGS Compliance
QC Systems to Comply with CAP, CLIA, & State Regulatory Guidelines
Dr. Robert Daber discusses how labs can establish laboratory QC systems to comply with CAP, CLIA, and state regulatory guidelines.
Liquid Biopsy
Development and Validation of Clinical ctDNA Cancer Assays
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
NGS-based Assay Validation and QC: A Complete Solution for the Clinical Sequencing Lab
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.
Case Study
Enabling Clinical Genomics with Highly Multiplexed and Patient-Like Reference Materials
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.
Assay Qualification
Ion Torrent Oncomine Myeloid Research Assay Qualification Protocol
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).
Case Study
Catalyzing Implementation of NGS-Based Tests
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.
Assay Development
How to Develop a Clinical NGS Assay Without Losing Your Mind or Your Shirt
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.