The Pharmabiotic Research Institute, as a partner of the Human Microbiome Action Consortium, is pleased to announce the publication of the paper, “State of the art and the future of microbiome-based biomarkers: a multidisciplinary Delphi consensus“, J. Rodriguez et al., this month in The Lancet Microbe.

Read the press release here.

The Human Microbiome Action consortium conducted a Delphi survey (coordinated by the PRI) to establish a consensus on the needs, challenges and limitations in qualifying microbiome-based biomarkers.

Join the PRI Regulatory Science experts along with the coordinators of the Human Microbiome Action EU Project during an online event to find out more about this important initiative.

Free webinar – gain insights into the future of microbiome-based biomarker development

Context – Biomarkers are pivotal in healthcare and medical 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 proceed with qualification or clinical implementation.

Delphi Survey, a recognized consensus tool – The questionnaire was developed by a scientific committee via literature review and expert interviews. The Survey elicited 114 and 93 responses submitted in the first and second rounds, respectively. This confirmed the experts’ confidence in the potential of microbiome-based biomarkers for several indications. The lack of validated analytical methods appears as a principal factor hindering these biomarkers’ qualification. Finally, the survey showed that clinical implementation would only be possible if “kitted” and validated molecular assays with simple interpretation are developed. This initiative serves as a foundation for designing and implementing public-private collaborative projects to overcome the challenges and promote clinical application of microbiome-based biomarkers.

Céline Druart, PRI Executive Director, shares;

“By identifying the factors which have hindered the validation of microbiome-based biomarkers, this paper should serve to clarify the future avenues necessary to design, finance and foster their emergence, and thus help to further realize the promise of microbiome science in clinical practice and personalized medicine. Thanks to our specific expertise in Microbiome Regulatory Science developed over more than 10 years, the PRI serves as a key resource in such collaborative projects.”

Find out more about the PRI here.

About the European IHMCSA Human Microbiome Action – https://humanmicrobiomeaction.eu/

Human Microbiome Action is an EU-funded Horizon 2020 project (grant agreement N° 964590) aiming to maximize the impact of European microbiome research and innovation to tackle the epidemics of chronic diseases.

At the core of the project’s mission is the ambition to create coherence and harmony in the ways microbiome research is and will be performed. By aligning, structuring and providing direction to EU microbiome research, the project will contribute to reach a health care system that takes into consideration the human microbiome.

The project ran for 3 years (2021-2024) and has been coordinated by France’s National Research Institute for Agriculture, Food and Environment (INRAE).