1 / 10

Final FDA Guidances on Next Generation Sequencing

Next Generation Sequencing (NGS) has become a critical technology in modern in vitro diagnostics (IVDs), enabling advanced genetic and genomic testing across a wide range of clinical applications. As the use of NGS-based tests continues to grow, regulatory clarity is essential to ensure analytical validity, clinical reliability, and patient safety.<br><br>https://operonstrategist.com/next-generation-sequencing/?utm_source=google&utm_medium=off-page&utm_campaign=offpage8

abhi142
Télécharger la présentation

Final FDA Guidances on Next Generation Sequencing

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Final FDA Guidances on Next Generation Sequencing (NGS) In Vitro Diagnostics (IVDs) • Understanding FDA expectations for NGS-based tests • Regulatory framework for modern genomic diagnostics

  2. Introduction to Next Generation Sequencing • Next Generation Sequencing (NGS) enables high-throughput DNA and RNA analysis • Allows simultaneous sequencing of multiple genes or entire genomes • Widely used in clinical diagnostics, research, and precision medicine

  3. Role of NGS in In Vitro Diagnostics • Supports detection of genetic variants linked to disease • Used in oncology, inherited disorders, and pharmacogenomics • Enables personalized and targeted treatment decisions

  4. Overview of FDA Final Guidances • FDA issued final guidances to clarify regulatory expectations for NGS IVDs • Focus on ensuring analytical and clinical validity • Supports innovation while maintaining patient safety and test reliability

  5. Guidance 1: Use of Public Genetic Variant Databases • Encourages use of public genetic variant databases • Databases help support clinical validity of NGS tests • Reduces need for duplicative clinical studies

  6. Benefits of FDA-Recognized Databases • Streamlined regulatory submissions • Increased confidence in variant interpretation • Consistent and transparent clinical evidence sources

  7. Guidance 2: Design & Analytical Validation of NGS IVDs • Emphasis on robust test design and system controls • Validation of sequencing accuracy and reproducibility • Assessment of bioinformatics pipeline performance

  8. FDA Expectations for Premarket Submissions • Demonstration of analytical validity • Accurate detection of genomic variants • Clear documentation of test limitations and performance

  9. Impact on IVD Manufacturers & Developers • Greater clarity in regulatory planning • Reduced uncertainty during product development • Supports efficient innovation in molecular diagnostics

  10. Conclusion & Reference • FDA guidances strengthen regulatory consistency for NGS IVDs • Promote reliable, high-quality genomic testing • Enable safer adoption of advanced sequencing technologies • Reference:https://operonstrategist.com/next-generation-sequencing/?utm_source=google&utm_medium=off-page&utm_campaign=offpage8

More Related