Microbiome testing in Europe: navigating analytical, ethical and regulatory challenges

Recommendations or actions, specific to the context of use of microbiome testing kits, are listed to improve the quality and the robustness of these test kits to meet expectations of end users (consumers, patients and healthcare professionals). The need for standardization, robust scientific evidence, qualification of microbiome-based biomarkers and a clear regulatory status in Europe are the main issues that will require attention in the near future to align laboratory development with societal needs and thus foster translation into daily health practice.

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Publication Details

Journal
Microbiome
Published
2024-12-18
DOI
https://doi.org/10.1186/s40168-024-01991-x
Citations
19
Primary Topic
Clostridium difficile and Clostridium perfringens research
Type
article
Field-Weighted Citation Impact
7.39

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article

Microbiome testing in Europe: navigating analytical, ethical and regulatory challenges

Magali Cordaillat‐Simmons, Andrey N. Shkoporov, Clara Desvignes, Stacie K. Loftus et al.
19 citations
Microbiome
Clostridium difficile and Clostridium perfringens research
7.39
article

Microbiome testing in Europe: navigating analytical, ethical and regulatory challenges

Magali Cordaillat‐Simmons, Andrey N. Shkoporov, Clara Desvignes, Stacie K. Loftus, Emmanuelle Maguin, Patrick Veiga, Moez Rhimi, Nelly Badalato, Camille d’Humières, Francesco Asnicar, Dirk Haller, Narciso M. Quijada, Federica Pinto, Vera V. Morozova, Jonel Trebicka, Robert Schierwagen, Mélanie Deschasaux, Mads Israelsen, Ida Falk Villesen, Aleksander Krag, Jos F. M. L. Seegers, Raphaela Joos, Arjun Sarathi, Carolina Alves Costa Silva, Hub Zwart, Alessio Fasano, Colin Hill, Joël Doré, R. Paul Ross, Philippe Ravaud, Lisa Derosa, Julie Rodriguez, Anandhi Iyappan, Manimozhiyan Arumugam, Bernard Berger, Marcus Joakim Claesson, Aïcha Kriaa, Hugh Ortega Breton, Isabelle Boutron, Fay Betsou, Nicola Segata, Aonghus Lavelle, Peer Bork, Laurence Zitvogel, Alexander Jarde, Federica Carraturo, Céline Druart, Hervé M. Blottière, Amira Metwaly, Zahra Hassani, Paul O’Toole, Nicolas Pons, Katy Boucher, Yolanda Godoy, Stephan Kampshoff, Pierre-Louis Prost, Austin Udocor, Typas Nassos, Hazenbrink Dienty Hendrina Maria Johanna, Raynald de Lahondès
article en
19 citations

Abstract

Recommendations or actions, specific to the context of use of microbiome testing kits, are listed to improve the quality and the robustness of these test kits to meet expectations of end users (consumers, patients and healthcare professionals). The need for standardization, robust scientific evidence, qualification of microbiome-based biomarkers and a clear regulatory status in Europe are the main issues that will require attention in the near future to align laboratory development with societal needs and thus foster translation into daily health practice.

MicrobiomeVol. 12(1)
Conservatoire National des Arts et Métiers (FR), Inserm (FR), Universidad de Salamanca (ES), Université Paris Cité (FR), AgroParisTech (FR), University College Cork (IE), Université Paris-Saclay (FR), European Food Information Council (BE), Microbiologie de l’alimentation au service de la santé (FR), Sorbonne Université (FR), Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement (FR), Université Sorbonne Paris Nord (FR), Sorbonne Paris Cité (FR), Laboratoire de Biotechnologie de l'Environnement (FR), Nestlé (Switzerland) (CH), Genoscope (FR), APC Microbiome Institute (IE), Centre de Recherche Épidémiologie et Statistique (FR), Virbac (France) (FR), Technical University of Munich (DE), Erasmus University Rotterdam (NL)
DNA Genotek, European Commission, Agence Nationale de la Recherche
Zero hunger
Openalex Percentile: Top 2%
Clostridium difficile and Clostridium perfringens research
7.39
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