With next-generation sequencing increasingly applied to diagnostics and disease surveillance, this fast-developing technology must also fit into a changing regulatory landscape. Elizabeth Linch examines how NGS fits with Europe’s In Vitro Diagnostic Regulation.
Genomic sequencing has become the central engine of modern precision medicine. Next-generation sequencing (NGS) technologies are transforming oncology, rare disease diagnostics, and infectious disease surveillance by enabling the simultaneous analysis of thousands of genetic variants. Landmark initiatives such as the Human Microbiome Project1 demonstrated the links between human and microbial genomes, paving the way for innovative diagnostics and targeted therapeutics. Yet, as these technologies advance, they must operate within evolving regulatory frameworks. In Europe, the In Vitro Diagnostic Regulation (IVDR) represents both challenge and opportunity as it seeks to ensure patient safety and quality while striving not to stifle innovation.
This article explores how NGS devices can align with IVDR principles, highlighting the unique complexities they pose while offering strategies for manufacturers, laboratories, and partners to successfully navigate this landscape.
NGS across the diagnostic landscape
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