Panel Q&A flags need for clinical benchmarks, method qualification and clearer regulation for microbiome products

In Q&A, council members and audience participants pressed panelists on practical next steps. Multiple questioners asked Sam Forry how to move from today’s 'wild west' of consumer microbiome tests to validated clinical benchmarks; Forry said both measurement traceability and clinical definitions of health are needed. "One is a lack of scope...and then secondly, a lack of clinical benchmarks," he said.

Panelists and questioners also debated regulatory pathways for live microbiome products and probiotics. Drew Schwartz argued for regulation appropriate to medical uses, noting hospitals often prohibit uncharacterized probiotics. The panel emphasized education for producers, incentives to shift away from routine antibiotics, and piloting qualification frameworks that can accommodate evolving sequencing instruments and methods.