Next-Generation Sequencing Assay Validation

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

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.

There are three key phases of bringing a clinical NGS assay into routine operation:

• Development (technology selection and optimization)
• Validation
• Ongoing assay QC protocols

"Nothing is more frustrating than finding a sample that is positive for a relevant variant but cannot be tested multiple times due to sample depletion."