Pandemic preparedness and response: In vitro diagnostic devices to tackle cross-border health threats -

Expected Outcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 5 “Unlocking the full potential of new tools, technologies and digital solutions for a healthy society”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

• The scientific and clinical communities, including health care providers and payers, as well as regulators, health systems and patients benefit from innovative diagnostic solutions that are better suited to tackle cross-border health threats.
• The scientific and clinical communities have access to novel and improved methodologies for detection of pathogens with pandemic potential in humans and for timely discovery of other health threats, such as chemical, radiological and nuclear threats, including considerations on detection in animals and environmental conditions (One Health approach).
• A diverse and robust pipeline of in vitro diagnostics[1] is available, increasing options for clinical deployment in case of an epidemic or pandemic.

Scope:

As shown by the COVID-19 pandemic, infectious diseases remain a major threat to health and health security in the EU and globally, this is also the case for other health threats that can be linked for instance to terror attacks. New cross-border health threats are expected to emerge in the coming years and therefore it is essential to promote advanced research of medical countermeasures that can be used to detect, prevent and treat in case of a new health emergency. One of the most important aspects in crisis preparedness times is to ensure the availability of diagnostics that can contribute to detecting and characterising health threats.

Proposals should develop and advance on new in vitro diagnostics relevant for detecting and characterising cross-border health threats and develop novel approaches to the development of medical countermeasures targeting threats identified by HERA[2].

Proposals should cover pathogens with pandemic potential in humans or other health threats, such as chemical, radiological and nuclear threats for which there are no existing diagnostics or where clinical practice could benefit from innovation. Emphasis should be put on the development of new diagnostics, innovative catch-all methodologies, or on the improvement of existing health technologies advancing diagnostics and characterisation of health threats, applying the One Health approach when relevant.

Proposals should aim to diversify and accelerate the global diagnostic research and development pipeline to tackle cross-border health threats, and to strengthen the current leading role of the EU in research and development, and therefore contributing to the work of the European Health Emergency Preparedness and Response Authority (HERA).

Attention should be paid to critical social factors such as sex, gender, age, socio-economic factors, ethnicity/migration, and disability.

Proposals should include a clear regulatory path to market in order to ensure future compliance with the legal requirements. Proposals should address several of the following areas:

• Proof-of-concept/early studies linked e.g. to performance evaluation of new diagnostics that facilitate screening, detection of the presence or exposure to a cross-border health threat or determination of infectious/disease status through human samples, included but not limited to the list of high impact health threats identified by HERA, as well chemical, radiological and nuclear threats for which there is a lack of in vitro diagnostics or existing diagnostics have a sub-optimal performance.
• Data-driven diagnostic and prognostic platforms with AI and other advanced data analytics functionalities, adaptable to respond to new and multiple pathogens/threats, e.g. covering prototype viruses.
• Innovative systems linked to high sensitivity/specificity profiles adaptable for broader use should be considered, such as portable, faster, more compact or accurate devices and technologies, including the possibility to develop point of care or self-tests.
• Innovative diagnostics sampling methods or samples bringing a significant improvement, such as less invasive sampling methods.

This topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.

Proposals should consider the involvement of the European Commission's Joint Research Centre (JRC) in regard to its experience on the performance evaluation of in vitro diagnostic devices, with respect to the value it could bring in providing an effective interface between research activities and regulatory aspects and/or to translating research results into validated test methods and strategies fit for regulatory purpose. In that respect, the JRC will consider collaborating with any successful proposal and this collaboration, when relevant, should be established after the proposal’s approval.

Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

[1] As defined in Guidance on Classification Rules for in-vitro Diagnostic Medical Devices for Regulation (EU) 2017/746 MDCG 2020-16 rev.1: https://ec.europa.eu/health/system/files/2022-01/md_mdcg_2020_guidance_classification_ivd-md_en.pdf

[2] https://health.ec.europa.eu/system/files/2022-07/hera_factsheet_health-threat_mcm.pdf

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