Industry Doubtful of Reference Databases in FDA Draft Guidance for NGS-Based Diagnostics

Although industry overall commended the FDA for developing guidelines for next-generation sequencing technologies for infectious disease diagnostics, stakeholders questioned whether the agency’s reference-grade databases would be sufficient to detect the vast majority of pathogens in the near future.

Microbiologics said in its comments that the reference databases listed in the draft guidance, such as the FDA-ARGOS and the NIST microbial standard reference materials, are not at a sufficient capacity to meet current diagnostics needs.

After extending the comment period from Aug. 11 to Sept. 12, the FDA received 10 comments on the draft guidance. Released May 13, the draft guidance spells out how the agency plans to regulate diagnostics that detect infectious disease organisms, antimicrobial resistance and virulence markers. — Tamra Sami