Experts call for standardisation in microbiome-based biomarker research
A new study highlights the potential of microbiome-based biomarkers whilst emphasising the need for validated analytical methods and international standards.
Consensus on microbiome biomarkers
A Delphi survey conducted by the EU-funded Human Microbiome Action consortium has shed light on the current state of microbiome-based biomarker research. The study, published in The Lancet Microbe on 5 September 2024 https://doi.org/10.1016/j.lanmic.2024.07.011 , reveals a strong confidence among experts in the potential of these biomarkers. However, it also underscores a significant barrier: the lack of validated analytical methods.
The survey, coordinated by the Pharmabiotic Research Institute (PRI), aimed to establish a consensus on the needs, challenges, and limitations in qualifying microbiome-based biomarkers. It gathered insights from 93 experts across 21 countries, providing a comprehensive view of the field.
The importance of biomarkers in healthcare
Biomarkers play a crucial role in modern healthcare and medical research. They serve multiple purposes, including disease diagnosis, monitoring disease progression, predicting risks, and potentially identifying treatment responders. In the rapidly advancing field of human microbiome research, hundreds of potential biomarkers are discovered annually. However, only a small fraction of these proceed to qualification or clinical implementation.
Céline Druart, Executive Director of the PRI, emphasised the significance of this study: “This paper should serve as a foundation to define future collaborative efforts needed to foster the emergence of microbiome-based biomarkers and promoting the application of microbiome science in clinical practice and personalized medicine.”
Overcoming challenges
The Delphi survey identified several key recommendations to address the challenges in microbiome-based biomarker research:
1. Increase awareness about microbiome-based biomarkers
2. Promote the adoption of standards and reference materials
3. Encourage interdisciplinary dialogue and collaborative projects
4. Align research and development with clinical expectations for translation into practice
One of the most critical findings is the need for implementing international standards and reference materials in analytical processes. This standardisation is seen as crucial for overcoming the current limitations in validating analytical methods.
A call for unified action
The Human Microbiome Action project, informed by the Delphi survey results, advocates for a unified approach to advance microbiome research. As part of this initiative, they extend an open invitation to join the European Microbiome Centres Consortium (EMCC).
Joël Doré, Coordinator of the Human Microbiome Action project, explained the rationale behind the EMCC: “We anticipated the creation of the EMCC as a means to secure the sustainability of the results of the project, as well as a forum open to collaborate on microbiome-based preventive and therapeutic strategies.”
The consortium emphasises that translating microbiome research into clinical applications requires a concerted effort from academia, industry, regulatory bodies, and policymakers. This collaborative approach is seen as essential for enhancing health diagnostics and treatments on a global scale.
The future of microbiome science
As the field of microbiome science continues to advance, the insights from this study provide a roadmap for future research and development. The implementation of standardised methods and reference materials is likely to accelerate the qualification of microbiome-based biomarkers, potentially leading to significant breakthroughs in personalised medicine.
The Human Microbiome Action project, a three-year initiative funded by the EU’s Horizon 2020 programme, has played a crucial role in harmonising human microbiome research. As it concludes in 2024, the establishment of the EMCC ensures that its work will continue to influence the field.
The PRI, as the European Microbiome Regulatory Science centre, is well-positioned to support the development of innovative products emerging from microbiome science. With its network of over 80 industry and academic organisations, it serves as a bridge between stakeholders in industry, academia, and EU regulatory representatives.
