Article Dans Une Revue Microbiome Année : 2024

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

1 BIAM - Institut de Biosciences et Biotechnologies d'Aix-Marseille (ex-IBEB)
2 PRI - Pharmabiotic Research Institute [Narbonne, France]
3 Genoscreen [Lille]
4 Nestlé Institute of Health Sciences SA [Lausanne, Switzerland]
5 Auteur indépendant
6 EREN [CRESS - U1153 / UMR_A 1125] - Nutritional Epidemiology Research Team | Equipe de Recherche en Epidémiologie Nutritionnelle
7 Voisin Consulting Life Sciences
8 EUFIC—European Food Information Council
9 UCC - University College Cork
10 TUM - Technische Universität Munchen = Technical University Munich = Université Technique de Munich
11 Erasmus University Rotterdam
12 UNINA - University of Naples Federico II = Università degli studi di Napoli Federico II
13 EBRIS - European Biomedical Research Institute of Salerno
14 Goethe University Frankfurt = Goethe-Universität Frankfurt am Main
15 EF CLIF - European Foundation for Study of Chronic Liver Failure [Barcelona]
16 WWU - Westfälische Wilhelms-Universität Münster = University of Münster = Université de Münster [Münster, Allemagne]
17 IBENS - Institut de biologie de l'ENS Paris
18 UMR 1015 - Immunologie des tumeurs et immunothérapie
19 Université Paris-Saclay
20 IGR - Institut Gustave Roussy
21 MGP (US 1367) - MetaGenoPolis
22 MICALIS - MICrobiologie de l'ALImentation au Service de la Santé
23 PhAN - Physiopathologie des Adaptations Nutritionnelles
24 KPL [Paris]
25 UPCité - Université Paris Cité
26 INSERM - Institut National de la Santé et de la Recherche Médicale
27 Centre d'épidémiologie Clinique [Hôtel-Dieu]
28 Hôpital Hôtel-Dieu [Paris]
29 METHODS [CRESS - U1153 / UMR_A 1125] - Methods of therapeutic evaluation of chronic diseases | Méthodes de l’évaluation thérapeutique des maladies chroniques
30 OUH - Odense University Hospital
31 SDU - University of Southern Denmark = Syddansk Universitet
32 AgroParisTech
Camille D’humières
  • Fonction : Auteur
Narciso M Quijada
  • Fonction : Auteur
Jos F M L Seegers
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Austin Udocor
  • Fonction : Auteur
Alessio Fasano
  • Fonction : Auteur
Yolanda Godoy
  • Fonction : Auteur
Peer Bork
Anandhi Iyappan
  • Fonction : Auteur
Typas Nassos
  • Fonction : Auteur
Carolina Alves Costa Silva
  • Fonction : Auteur
Nicolas Pons
Zahra Hassani
  • Fonction : Auteur
Pierre-Louis Prost
  • Fonction : Auteur
Fay Betsou
  • Fonction : Auteur
Mads Israelsen
  • Fonction : Auteur
Ida Falk Villesen
  • Fonction : Auteur
Dirk Haller
  • Fonction : Auteur
Paul Ross
  • Fonction : Auteur
Paul O’toole
  • Fonction : Auteur
Marcus Claesson
  • Fonction : Auteur
Raphaela Joos
  • Fonction : Auteur
Colin Hill
  • Fonction : Auteur
Andrey Shkoporov
  • Fonction : Auteur
Saba Loftus
  • Fonction : Auteur
Katy Boucher
  • Fonction : Auteur
Manimozhayan Arumugam
  • Fonction : Auteur
Arjun Sarathi
  • Fonction : Auteur
Vitalina Morozova
  • Fonction : Auteur
Nicola Segata
  • Fonction : Auteur
Francesco Asnicar
  • Fonction : Auteur
Federica Pinto
  • Fonction : Auteur
Céline Druart
  • Fonction : Auteur

Résumé

Background In recent years, human microbiome research has flourished and has drawn attention from both healthcare professionals and general consumers as the human microbiome is now recognized as having a significant influence on human health. This has led to the emergence of companies offering microbiome testing services. Some of these services are sold directly to the consumer via companies' websites or via medical laboratory websites.

Methodology

In order to provide an overview of the consumer experience proposed by these microbiome testing services, one single faecal sample was sent to six different companies (five based in Europe and one based in the USA). Two out of the six testing kits were commercialized by medical laboratories, but without any requirement for a medical prescription. The analyses and reports received were discussed with a panel of experts (21 experts from 8 countries) during an online workshop.

Results

This workshop led to the identification of several limitations and challenges related to these kits, including over-promising messages from the companies, a lack of transparency in the methodology used for the analysis and a lack of reliability of the results. The experts considered the interpretations and recommendations provided in the different reports to be premature due to the lack of robust scientific evidence and the analyses associated with the reports to be of limited clinical utility. The experts also discussed the grey areas surrounding the regulatory status of these test kits, including their positioning in the European market. The experts recommended a distinction between regulatory requirements based on the intended use or purpose of the kit: on the one hand, test kits developed to satisfy consumer curiosity, with a clear mention of this objective, and no mention of any disease or risk of disease, and on the other hand, in vitro diagnostic (IVD) CE-marked test kits, which could go deeper into the analysis and interpretation of samples, as such a report would be intended for trained healthcare professionals.

Conclusions 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 microbiomebased 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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Dates et versions

hal-05133447 , version 1 (27-06-2025)

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Julie Rodriguez, Magali Cordaillat-Simmons, Nelly Badalato, Bernard Berger, Heloise Breton, et al.. Microbiome testing in Europe: navigating analytical, ethical and regulatory challenges. Microbiome, 2024, 12 (1), pp.258. ⟨10.1186/s40168-024-01991-x⟩. ⟨hal-05133447⟩
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