The FDA has extended the comment period from Aug. 11 to Sept. 12 for its draft guidance on infectious disease next-generation sequencing diagnostic devices.
Released May 13, the guidance spells out how the agency plans to regulate diagnostics that detect infectious disease organisms, antimicrobial resistance and virulence markers.
Tagged as Class II devices, the FDA will regulate infectious disease NGS Dx devices based on a “one-system” approach, similar to the way it regulates molecular-based diagnostic devices. The guidance notes that in contrast to human sequencing diagnostics, infectious disease sequencing diagnostics generally require rapid and actionable results, “as delayed or incorrect diagnoses can result in fatalities.”
The guidance was drawn from stakeholder input during an April 13, 2015 meeting that stressed the need for more advanced testing to better detect and identify infectious disease organisms. Stakeholders stressed that next-generation sequencing can replace previous methods with a single approach ().
The guidance proposes the use of an alternative comparator to validate NGS-based tests for infectious diseases. To that end, the agency developed the FDA-ARGOS [FDA dAtabase for Regulatory Grade microbial Sequences] database to supply validated regulatory-grade microbial genomic sequence entries collected from public databases.