The European Union-funded Human Microbiome Action consortium conducted a Delphi survey, coordinated by the Pharmabiotic Research Institute (PRI), to establish a consensus on the needs, challenges and limitations in qualifying microbiome-based biomarkers. The study, published in The Lancet Microbe, shows strong confidence among experts in the potential of microbiome-based biomarkers, but highlights the critical barrier posed by the lack of validated analytical methods. To overcome this problem, the implementation of international standards and reference materials in analytical processes is essential.

Biomarkers are fundamental in medical and health research. They can be used to diagnose diseases, track disease progression, predict risks, and potentially predict treatment responders. In the field of human microbiomes, hundreds of potential biomarkers are discovered each year, but only a few progress to clinical qualification or implementation. "This document should serve as a basis for defining future collaborative efforts needed to promote the emergence of microbiome-based biomarkers and advance the application of microbiome science in clinical practice and personalized medicine," explains Céline Druart , executive director of the Pri.

The resulting recommendations to overcome the challenges are based on a Delphi survey of 93 experts from 21 countries: 1) Raise awareness of microbiome-based biomarkers; 2) Promote awareness and adoption of standards and reference materials; 3) Promote interdisciplinary dialogue and collaborative projects; 4) Align research and development with clinical expectations for translation into clinical practice; 5) Adopt a unified approach.

The Human Microbiome Action project, guided by insights from a comprehensive Delphi survey, promotes a unified approach by extending an open invitation to join the European Microbiome Centres Consortium (EMCC) to foster interdisciplinary collaboration and advance microbiome research. “We envisioned the creation of the EMCC as a means to ensure the sustainability of the project’s results, as well as an open forum for collaboration on microbiome-based preventive and therapeutic strategies,” said Joël Doré , Human Microbiome Action project coordinator.

Concerted effort by academia, industry, regulators and policy makers is believed to be critical to translate microbiome research into clinical applications, thereby improving healthcare diagnosis and treatments globally.