NGS Assay Development

NGS 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 quickly and cost-effectively. It discusses specific ways to overcome the top three assay development challenges faced by clinical laboratories.

NGS QC
Finally, Reliable Quality Control for NGS Labs
NGS assay implementation can be extremely costly, even more so if you don’t follow best practices. Learn how highly multiplexed NGS reference materials can help you speed development, validate more robustly, and implement better clinical genomics assays.

NGS QC
Case Study: Using Robust QC to Improve Cancer Care
This case study details how Navican used SeraCare's complete QC solution to build a best-in-class quality control protocol. They discuss the implementation of both Seraseq clinical genomics reference materials, and iQ NGS QC Management software.
NGS Assay Validation and QC

Survey Report
Trends in Clinical NGS QC Management: Results from a Practitioner Survey
By focusing on 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 to gain greater insight into the QC habits and best practices of the clinical NGS community worldwide.

Validation eBook
Next-Generation Sequencing Assay Validation
A practical guide 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.

Case Study
Seven Benefits of Clinical Genomics Universal Standardization
Clinical diagnostics veteran Dr. Andrea Ferreira-Gonzalez discusses the results of an interlaboratory evaluation of standardized reference materials for tumor profiling.

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 prior to routine deployment 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.

NGS QC
2 Tools For Overcoming Your Clinical Lab's Toughest QC Challenges
Whatever practices you use for NGS assay development, validation, and performance monitoring, your goal is the same: Your results must be as accurate, precise, and consistent as possible.

Liquid Biopsy
Seraseq ctDNA: A Breakthrough QC Technology
A technical explanation of our proprietary reference material technology that overcomes the problems of low library yield and low library complexity that using sheared cell-line DNA presents.

NGS QC
Achieving High Levels of Accuracy from NGS Assays in Clinical Laboratories
This white paper details the panel at the 2017 Precision Medicine World Conference (PMWC), "Achieving Accurate NGS Test Results." Panelists discuss achieving high levels of accuracy with NGS, giving key insights and an in-depth look at specifics that contribute to variability.

Data QC
Automate the QC Data Analysis of Your Clinical NGS Test
Save time and money collecting and organizing QC data for audits and troubleshooting. Francine de Abreu, PhD, discusses several ways in which using automated QC tracking software is critical for high-throughput validation and routine clinical use.
Infectious Disease

Assay Development
AccuPlex Technology for Rapid Development of Molecular Diagnostic Assays in Response to Viral Infectious Diseases
This white paper details how AccuPlexTM recombinant virus technology enables replication-defective virus particles that are commutable in any sample matrix and closely mimic pathogenic virus found in clinical samples.

App Note
Comparison of the KPL BacTrace Anti-Salmonella CSA-Plus Antibody to Two Other Anti‑Salmonella Species Antibodies in an Indirect ELISA
Learn why KPL BacTrace antibodies outperform both polyclonal and monoclonal antibodies in an indirect ELISA, and how we achieve the broad reactivity of a polyclonal antibody combined with the specificity of a monoclonal antibody.