Viromarkers – Virus related biomarkers to improve management of chronic conditions

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Why?

The overall aim of VIROMARKERS is to define virus-related biomarkers to improve management of chronic diseases, including biomarkers of response to antiviral treatment of persistent viral infections and virome features as indicators of disease progression in immunosuppressed people. Validation or demonstration of the technologies required to measure the candidate biomarkers is an integral part of the project objectives.

This project makes that transition possible by addressing the following needs:

  • To enhance the understanding and application of viral quantification as a diagnostic biomarker in immunocompromised populations.
  • To improve the management of chronic viral diseases, particularly in immunosuppressed individuals.
  • Because certified assays currently exist for only a few biomarkers (e.g., HDV RNA), while others (like total HIV DNA) are expected to obtain certification soon. The validation of new biomarkers is fundamental for a precision medicine approach.
  • To generate the experimental data necessary to move prototype methods through the regulatory steps necessary to reach clinical application.

 

What?

Viromarkers is a public-private partnership aiming at the development of biomarkers that would revolutionise the care of people living with HIV and hepatitis D, as well as stem cell transplant patients at risk of cytomegalovirus (CMV) infection or reactivation. The project is a pioneering cross-sectoral initiative granted by the Innovative Health Initiative (IHI) funding scheme.

 

With whom?

The initiative brings together over 50 researchers, industry experts, and community partners from across Europe. The collaboration unites leading virologists, clinicians, bioinformaticians, and biotech experts. It involves pharma and diagnostic companies together with care and research institutions, community representatives, and a European regulatory body.

EATG will ensure the meaningful input of the community by integrating the perspectives of people living with HIV and other affected populations in relevant documents and processes of the research and communication.

 

How?

VIROMARKERS will evaluate virus-related biomarkers including both biomarkers of response to antiviral treatment (for HIV and HDV) and virome features (CMV and TTV) as indicators of disease progression in immunosuppressed people. The project includes all the preliminary lab activities to set up or refine investigational methods to measure the biomarker(s) considered. Structured around multiple specialised work packages (WPs), the project unites scientific expertise with industrial innovation to validate specific biomarkers.

 

For what outcome?

The ultimate goal is to translate these scientific discoveries into approved, real-world clinical tools that directly benefit patients. Specifically, the project aims to:

  • To improve diagnostic and prognostic tools for better healthcare outcomes in people with HIV and those undergoing hematopoietic stem cell transplantation.
  • Assay setup within VIROMARKERS will generate the experimental data necessary to move prototype methods through the regulatory steps necessary to reach clinical application.
  • The project’s findings will be made available to the scientific community, regulators, and healthcare providers, ensuring widespread adoption of validated biomarkers in clinical practice and bringing about innovative results into the clinics.

EATG’s role 

EATG will ensure the meaningful input of the community by integrating the perspectives of people living with HIV and other affected populations in relevant document and processes of the research. This is crucial for the ethical implementation of viral quantification and the development of diagnostic biomarkers that address patient needs.

EATG is primarily involved in the following work packages (WPs):

  • WP1: Biomarkers of susceptibility to broadly neutralising HIV antibodies.
  • WP3: Viral quantification as a diagnostic biomarker in immunocompromised populations.
  • WP5: Dissemination, exploitation, and regulatory activities.

 

Community Advisory Panel

Alain Volny-Anne
Sean Hosein

 

Community Representation at the External Ethics Advisory Board (EEAB)

Siegfried Schwarze

 

EATG contact person(s):Giorgio Barbareschi – Giorgio.barbareschi@eatg.org
Duration of the project/initiative:1 February 2025 – 31 January 2028
Project/Initiative Leader:EuResist Network
Project/initiative Main Partner(s) :Altona Diagnostics GmbH (DE); ASST Santi Paolo e Carlo (IT); Diatheva S.r.l. (IT); EuResist Network (IT); European AIDS Treatment Group (DE); European Liver Patients Association (BE); Heinrich-Heine-Universität Düsseldorf (DE); InformaPRO (IT); Karolinska Institutet (SE); Menarini Diagnostics S.r.l. (IT); MIB  GmbH (DE); Policlinico of Milan (IT); Paul-Ehrlich-Institut (DE); Qiagen GmbH (DE); Roboscreen GmbH (DE); S.I.A.L. S.r.l. (IT); University of Rome Tor Vergata (IT); University of Siena (IT); University College London (UK); University Hospital of Cologne (DE)
Budget:Total grant amount € 4 358 845,00

EATG Budget € 50 000

Main Funding Sources:Innovative Health Initiative Joint Undertaking (IHI JU)
Links:https://www.viromarkers.eu/
Communication Disclaimer:The Viromarkers project is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement No 101194735. The JU receives support from the European Union’s Horizon Europe research and innovation programme and COCIR, EFPIA, Europa Bío, MedTech Europe, and Vaccines Europe and Roboscreen.

Views and opinions expressed are however, those of the author(s) only and do not necessarily reflect those of the aforementioned parties. Neither of the aforementioned parties can be held responsible for them.

 

 

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