Demystifying Analytical Validation While Onboarding NGS Tests

Next-generation sequencing (NGS) is quickly becoming the go-to tool for testing labs looking to bring on additional tests requiring smaller tissue samples, reduced time to results, and increased efficiencies and profitability. While these labs are faced with inherent challenges—such as staffing resources and competencies, testing volumes, and reimbursement—more and more are deciding that insourcing commercially available NGS tests is the way to go for the greatest return on investment. However, adapting to variability in the compliance environment, applying requirements to molecular assays, and knowing the documentation needed can pose additional risk.

In this webinar, you will hear about the importance of analytical validation (AV) in the process validation workflow when introducing NGS-based testing. An AV specialist will summarize the College of American Pathologists (CAP) checklist for NGS tests, the New York State Department of Health (NYSDOH) guidelines, and the importance of demonstrating utility as relating to the AV consulting services provided by Thermo Fisher Scientific. The webinar will cover the importance of using the CAP checklist and NYSDOH guidelines to aid in the launch of new molecular tests.  

Learning objectives:

• Recognize the requirements outlined in the CAP checklist when onboarding new NGS tests
• Discuss how Thermo Fisher Scientific aligns their AV consulting services to the CAP and NYSDOH guidelines
• Discuss the challenges faced by molecular testing labs when bringing new tests online