Julie Rodriguez, PhD, Zahra Hassani, PhD, Carolina Alves Costa Silva, PhD,∙Fay Betsou, PhD, Federica Carraturo, PhD,∙Prof Alessio Fasano, MD,∙Mads Israelsen, PhD Anandhi Iyappan, PhD, Aleksander Krag, PhD, Amira Metwaly, PhD, Robert Schierwagen, PhD, Prof Jonel Trebicka, PhD,∙Prof Hub Zwart, PhD, Joel Doré, PhD, Magali Cordaillat-Simmons, PhD,∙on behalf of the Human Microbiome Action consortium.
The Lancet Microbe 2024 | Published Online https://doi.org/10.1016/ j.lanmic.2024.07.011
Although microbiome signatures have been identified in various contexts (ie, pathogenesis of non-communicable diseases and treatment response), qualified microbiome-based biomarkers are currently not in use in clinical practice. The Human Microbiome Action consortium initiated a Delphi survey to establish a consensus on the needs, challenges, and limitations in developing qualified microbiome-based biomarkers. The questionnaire was developed by a scientific committee via literature review and expert interviews. To ensure broad applicability of the results, 307 experts were invited to participate; 114 of them responded to the first round of the survey, 93 of whom completed the second and final round as well. The survey highlighted the experts’ confidence in the potential of microbiome-based biomarkers for several indications or pathologies. The paucity of validated analytical methods appears to be the principal factor hindering the qualification of these biomarkers. The survey also showed that clinical implementation of these biomarkers 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.
