Project description
Faster, less expensive, and more efficient blood assay for tuberculosis infection
Tuberculosis is present in all countries. It is the leading cause of death globally from a single infectious agent, yet it is curable and preventable. Early screening can help. About a fourth of the global population has been infected with tuberculosis-causing bacteria and about 8-10 % of these people will go on to develop tuberculosis. Screening for infection is currently done with an expensive, technically complex blood assay requiring 2-4 days of incubation. The ERC-funded FastTBItest has a patent-pending alternative that detects responses within several hours. The team will assess the test’s clinical feasibility as an in vitro diagnostic, identify EU regulations to be addressed, and pave the way to commercialisation.
Objective
Latent tuberculosis infection (TBI) occurs when someone is infected with Mycobacterium tuberculosis but does not have active TB disease. Those with TBI are at risk of developing active TB, with 8–10% progressing without antibiotic treatment, causing significant societal and economic impacts. Testing higher-risk groups, including immunocompromised individuals (e.g. those on immunosuppressive therapy, HIV-positive), close contacts with active TB cases, healthcare workers, and people from high TB prevalence countries (e.g. refugees), is crucial for TB control. The interferon-gamma release assay (IGRA) is a primary TBI test, detecting T cell immune responses to M. tuberculosis in blood. However, IGRA is technically challenging, requires long incubation times (24–48 hours), and incurs high costs (>100 EUR/test). These factors hinder the widespread screening of high-risk populations recommended by the WHO.
We have developed a new technique, ProliSpot (patent pending), which detects antigen-specific T cell responses within several hours after collecting a blood sample and potentially overcomes the limitations of IGRA. This project's goal is to determine ProliSpot's in vitro diagnostic (IVD) potential for TBI testing.
To achieve this, we will assess clinical feasibility by testing blood samples from TB patients and control subjects and compare the results with IGRA. Moreover, we will identify the subsequent steps needed for clinical development, particularly for the Investigational Medical Device Dossier (IMDD) and other requirements of the EU in vitro diagnostics regulations (IVDR). We will also perform pre-commercialization studies and define funding and networking strategies. Given that TBI testing is crucial for TB control, tens of thousands are screened annually in Europe, there is a societal need for increased TBI screening, and improved TBI testing methods are needed, the project's societal and economic impact is expected to be significant.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
- medical and health sciences clinical medicine pneumology tuberculosis
- social sciences sociology demography human migrations
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Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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HORIZON.1.1 - European Research Council (ERC)
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Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
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Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
HORIZON-ERC-POC - HORIZON ERC Proof of Concept Grants
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Call for proposal
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Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) ERC-2024-POC
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9712CP Groningen
Netherlands
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