When tests don’t fit the rules: regulatory challenges for agnostic metagenomic next-generation sequencing in infectious diseases diagnostics
This mini-review synthesizes validation and regulatory challenges unique to mNGS-based diagnostics and describes how laboratories and developers currently navigate available pathways, focusing on core analytical and clinical validation challenges.
Nick P. G. Gauthier, Vishal Kapoor, David C. Gaston et al.
· Journal of Clinical Microbio... · 0 citations