Experts urge biomarkers and new payment approaches to move microbiome therapies from approval to patient access

Dr. Michael Woodworth, an infectious‑disease clinician at Emory University School of Medicine, told the Council that antibiotic‑resistant organisms persistently colonize patients and that "there are no FDA‑approved therapies to reduce colonization in the gut." He framed microbiota‑targeted interventions as tools to prevent downstream infections and death and said the field needs biomarkers to identify high‑risk patients and make trials practicable.

"Biomarkers allow us to find patients at the greatest risk and allow more efficient trials," Woodworth said, noting that susceptibility and prognostic biomarkers could permit trials sized in the hundreds instead of thousands by enriching for events. He cited the Sentinel REACT and DAV132 experiences as examples of how heterogeneous endpoints and enrollment challenges can derail studies.

Woodworth also pressed for policy work to translate approvals into real‑world treatments. He recommended that CMS evaluate coverage and site‑of‑care policy and suggested linking infection‑penalty frameworks to incentives for microbiota interventions and research. "We should seek to identify ways to fund interventional clinical trials and networks of microbiota therapies," he told the panel, arguing that approval alone has not produced broad access.

Panelists and questioners probed drivers of unequal uptake. Woodworth described preliminary Metro‑Atlanta analyses showing racial and social‑vulnerability differences in who receives microbiota therapies and said payment denials are a common reason eligible patients do not receive treatment. Jacinda Abdul‑Mutakabbir highlighted differences within Medicare plan types (fee‑for‑service versus Medicare Advantage) as one potential mediator of access.

The panel did not take formal policy votes but pointed to concrete next steps: expand translational clinical‑trial networks, pursue biomarker qualification with FDA/NIH frameworks, and open discussions with CMS on coverage pathways. Woodworth suggested HHS should also measure who receives these therapies as a performance metric for equitable access.