The realm of human microbiomes—trillions of microorganisms residing in various sites such as the oral cavity, skin, and gastrointestinal tract—is increasingly recognized for its profound influence on health and disease.
Disruptions in the microbiome are linked to a wide array of conditions, from inflammatory and metabolic diseases to cancer.
The identification and qualification of microbiome-based biomarkers, therefore, represent a pivotal advancement in diagnostics and treatment efficacy.
The Delphi Survey Initiative
A recent initiative by the Human Microbiome Action consortium, highlighted in a publication in Lancet Microbeand coordinated by the Pharmabiotic Research Institute (PRI), aimed to establish a consensus on the development of these biomarkers through a Delphi survey.
This survey method, renowned for its effectiveness in achieving consensus among a broad panel of experts, involved two rounds of rigorous questionnaires completed by specialists across multiple disciplines.
Key findings and challenges
The study revealed a robust belief in the potential of microbiome-based biomarkers to significantly advance clinical practices for various diseases, including cancer and metabolic disorders.
However, the journey from biomarker discovery to clinical implementation is fraught with challenges. Among these, the most daunting is the lack of standardized, validated analytical methods, which hampers the qualification process for clinical use.
Experts also highlighted the scarcity of large-scale, validated clinical data and the variable nature of human microbiomes, which complicates the establishment of clear, universally applicable biomarker standards.
Furthermore, the need for effective communication and collaboration between researchers, clinicians, and regulatory bodies was emphasized to accelerate the development of validated biomarkers.
Future directions and innovations
Céline Druart, Executive Director of the PRI, notes, “This paper should serve as a foundation to define future collaborative efforts needed to foster the emergence of microbiome-based biomarkers and promote the application of microbiome science in clinical practice and personalized medicine.”
The consensus points towards a pressing need for public-private partnerships to address these challenges and for enhanced funding mechanisms to support this vital research.
Innovations in molecular assay development, aimed at simplifying and standardizing microbiome analysis, are crucial for integrating these biomarkers into routine clinical practice. Joël Doré, Coordinator of the Human Microbiome Action project, also announces the creation of the European Microbiome Centres Consortium (EMCC), which aims to secure the sustainability of project results and foster collaboration on microbiome-based preventive and therapeutic strategies.
Embracing a unified approach
The Human Microbiome Action project promotes a unified approach, extending an open invitation to join the EMCC to foster interdisciplinary collaboration and advance microbiome research.
The development and application of microbiome-based biomarkers hold the promise not only for improving diagnostic accuracy and treatment outcomes but also for paving the way towards more personalized medicine approaches.
By fostering a deeper understanding of the microbiome’s role in health and disease, researchers and clinicians can unlock new therapeutic avenues and refine existing treatment modalities, ensuring better patient outcomes and optimized healthcare strategies. The concerted effort of academia, industry, regulatory bodies, and policymakers is vital for translating microbiome research into clinical applications, thereby enhancing health diagnostics and treatments globally.
