Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases

Abstract:

The field of genomic testing is dynamic, building off of increasing amounts of data and a rapidly evolving technology base. While current regulatory approaches are appropriate for conventional diagnostics that measure a limited number of analytes...

Type:

Report

Date:

2018

Site link:

Read the Report: Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases

URL Citation:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-design-development-and-analytical-validation-next-generation-sequencing-ngs-based

Institution:

Food and Drug Administration

LawSeq^SM Record Last Modified:

04/15/2026