Title: NIST-FDA Workshop Report: Standards for Pathogen Detection via Next Generation Sequencing
Summary:
The National Institute of Standards and Technology (NIST) and the U.S. Food and Drug Administration (FDA) recently held a workshop to discuss the development of standards for pathogen detection using next-generation sequencing (NGS) technologies. The workshop aimed to establish reference materials, data, and methods for evaluating the performance of NGS-based pathogen detection devices and assays.
Key points:
1. The workshop focused on developing standards for mixed pathogen detection in complex samples, such as clinical and environmental samples, using both shotgun metagenomic sequencing and targeted resequencing approaches.
2. Attendees included clinicians, public health professionals, industry representatives, and academic and government laboratory experts.
3. The workshop discussed the importance of reference materials for assessing the sensitivity and specificity of NGS-based pathogen detection methods.
4. Mixed microbial genomic DNA reference materials were proposed as quality control tools for these diagnostics.
5. The FDA is working on an adaptive regulatory approach for evaluating NGS-based diagnostic tests.
The development of these standards is crucial for the validation and acceptance of NGS-based pathogen detection methods in clinical and public health settings. The workshop marked an important step towards establishing a framework for the development and implementation of these standards.
Source: https://www.nist.gov/mml/bbd/core-capabilities/nist-fda-workshop-standards-pathogen-detection
Keywords: Pathogen Detection, Next-Generation Sequencing (NGS), Reference Materials
