2019-06-012 - AFIB - Diagnosis markers for atrial fibrillation

AFIB

2019-06-012

In vitro method for diagnosing AF in a subject, which is based on the combination of blood biomarkers. TRL 4 as the biomarkers panel has been successfully tested on clinical samples from a cohort of 100 patients

Problem: Atrial fibrillation (AF) is difficult to detect due to its paroxysmal and asymptomatic nature, especially in early stages. Traditional screening methods and the current diagnostic gold standard lack sensitivity and practicality, leading to underdiagnosis, particularly in elderly populations. Systematic screening programs have shown limited impact, and there's a need for more effective, non-invasive tools to identify patients at risk. Solution: The project proposes a blood-based biomarker panel (NT-proBNP, ST-2, R-spondin 3, Factor IX, TIMP2) to improve early detection of atrial fibrillation and help primary care physicians identify candidates for extended cardiac monitoring. Initial validation in a 100-patient cohort showed high sensitivity (90.3%) and specificity (85.7%), with predictive performance comparable to or exceeding device-based diagnostics. A rapid immunochromatographic strip test for use in clinical settings is also in development.

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The business model could focus on technology co-development or licensing to a diagnostics company (e.g., Roche Diagnostics), leveraging their manufacturing and distribution capacity. However, due to freedom-to-operate limitations (NT-proBNP under patent by Roche) and the lack of reproducibility in a 400-patient cohort, the project’s commercial path is constrained unless new biomarkers are introduced or IP strategies are revised.

There is a clear unmet need for more accurate, scalable, and cost-effective AF detection tools, particularly suited for primary care use in patients over 65 years old — the main risk group for AF. Early detection can significantly reduce the risk of stroke and healthcare burden, but current diagnostics are invasive, expensive, or insensitive to paroxysmal forms. A validated blood test would address this clinical gap and enable more effective screening strategies.

The primary target market consists of: Primary care clinics and physicians, especially in regions with aging populations. Cardiology departments and outpatient diagnostic centers. Health systems or insurers seeking more cost-effective AF screening tools. Secondary market: In vitro diagnostic companies looking to integrate new biomarkers into their platforms. Geographically, the market includes Europe, North America, and aging populations in Asia.

This technology disrupts the current AF diagnostic paradigm by replacing intermittent, device-based, or ECG-heavy methods with a simple, blood-based biomarker test. Its integration into primary care practice offers a scalable, less invasive solution that could shift the diagnostic model from specialist to generalist settings, enabling proactive screening and earlier interventions. The immunochromatographic strip format adds point-of-care utility, making AF detection faster, more accessible, and potentially more cost-effective.

PCT/EP2020/061467, EP19382321.8

We are looking for a licensee, the patent costs are now be payed by the research groups involved .

AFIB technology allows for reliable and early diagnosis of paroxysmal AF with good sensibility and specificity, even in asymptomatic patients. The global objective of the project is the development and validation of a screening method for AF at primary care.