Launch of the Viromarkers project: a Pioneering Initiative to Advance Virus-Related Biomarkers for Chronic Disease Management

April 2, 2025

The Viromarkers project will be launched in Rome, Italy, on April 3 and 4.  More than fifty researchers, industrial and community partners will gather from several European countries to give start to this ambitious cross-sectoral, public-private research partnership.

Supported by the Innovative Health Initiative Joint Undertaking (IHI JU) and its members, Viromarkers brings together researchers from public institutions, industries from the European life science landscape and patients’ associations from across Europe to define and validate biomarkers that can revolutionise patient care for individuals affected by HIV, Hepatitis D (HDV), and Cytomegalovirus (CMV) infections. The aim is to enhance treatment response monitoring, optimise therapeutic strategies, and provide a deeper understanding of disease progression in immunosuppressed individuals.

The project is structured around multiple work packages (WPs), each targeting specific biomarker developments. “The project is financed by a public-private partnership and brings together researchers from public institutions, industries from the European life science landscape and patients’ associations” said Francesca Incardona, Project Coordinator of Viromarkers, and CEO of EuResist Network, a European Grouping fighting HIV resistance and other infectious diseases. “We are thrilled that we were able to combine the true scientific interests of our biomedical community with the needs of outstanding innovative biotech industries into a common project, an exciting new adventure with a clear potential impact on the lives of many” adds Incardona.

WP1 focuses on HIV-1 susceptibility to Broadly Neutralising Antibodies (bNAbs) and the development of predictive models to determine HIV-1 resistance or susceptibility to bNAbs. The final goal is to aid the selection of optimal treatments for people living with HIV. “Anti-HIV bNAbs hold the potential to address significant gaps in HIV treatment and prevention. They represent a new class of therapies for individuals with multidrug-resistant viruses, as well as for those seeking to optimise their treatment by switching to long-acting options. However, it is crucial to focus on virus variability and ensure that the appropriate bNAbs are selected for the specific viral strain. This is where Viromarkers comes into play, integrating virology, bioinformatics, and statistical learning (or AI) to guide bNAb selection.” stated Maurizio Zazzi, leader of WP1, professor of Microbiology at the Department of Medical Biotechnology of the University of Siena.

Valentina Svicher is professor of Microbiology and Clinical Microbiology at the University of Rome Tor Vergata and leads WP2, which is centred around HDV treatment response. Her team oversees the development of novel HDV biomarkers to optimise the administration of Bulevirtide, the first target therapy for HDV and the most commonly used treatment at present. “HDV is the smallest human RNA virus causing the most severe form of hepatitis. Nevertheless, it has remained orphan of effective drugs for several years. Only recently has the entry inhibitor Bulevirtide been introduced into clinical practice. Although Bulevirtide is revolutionizing the management of people with chronic HDV infection, so far the factors that can predict the virological response to this drug have not been clarified. In this light, WP2 aims to create a platform of classic and new biomarkers, fundamental to optimize the monitoring of patients receiving this drug” emphasised Svicher.

“The validation of novel biomarkers is crucial for a precision medicine approach to people infected with chronic viral infections. Validation or demonstration of technologies required to measure new candidate biomarkers is an integral part of the project objectives” added Francesca Ceccherini Silberstein, professor of Microbiology and Clinical Microbiology at the University of Rome Tor Vergata, and WP3 leader. WP3 is focused on viral quantifications as diagnostic biomarkers for the management of chronic infections in immunocompromised populations. The aim within this WP is to validate CMV-RNA and TTV-DNA as early indicators of infection or reactivation of CMV infection in transplant patients, as well as HIV-DNA as an indicator for viral rebound in virologically suppressed HIV infected individuals.

Sabina Schaal leads the Viromarkers project on the industrial front, representing altona Diagnostics. The medical diagnostic company develops and manufactures in vitro diagnostic tests for PCR-based detection of pathogens. “Viromarkers is an exceptional collaboration at the intersection of cutting-edge science and industrial innovation. We are honoured to contribute our expertise in molecular diagnostics to drive forward novel solutions” states Schaal.

As part of Viromarkers, 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. This is crucial for the ethical implementation of viral quantification and the development of diagnostic biomarkers that address patient needs.

Specifically, EATG will provide input from the point of view of community in:

• WP1 (Biomarkers of susceptibility to broadly neutralising HIV antibodies): Contribution to be defined with the WP lead.
• WP3 (Viral quantification in immunocompromised populations): EATG will provide input in the CMV and the HIV DNA study protocol
• WP5 (Dissemination, Exploitation & Regulatory Activities): EATG will also provide community input to dissemination activities.

By uniting leading scientific expertise with industrial innovation, the project is set to deliver solutions that are not only scientifically robust but also practical and transformative for real-world healthcare. By bridging the gap between research and industry, Viromarkers will pave the way for novel diagnostic tools that enhance precision, guide treatment decisions, and ultimately improve patient outcomes. 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 for the greater benefit of society.

The consortium will gather in Rome, Italy on the 3rd and 4th of April for the official project kickoff – a valuable opportunity to strengthen collaboration, and align on key objectives and activities.

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, Vaccines Europe and Roboscreen. The total cost of the project is € 4 358 845,00 with an EU contribution of € 2 329 503,75 and a contribution from industrial partners worth € 2 029 341,25.

For more information about the Viromarkers project, visit www.viromarkers.eu, https://cordis.europa.eu/project/id/101194735, https://www.euresist.org/viromarkers, and follow the project on its social media channels for live updates and a behind-the-scenes look at the kickoff event.