Validation of a point-of-care h-fabp test for a rapid exclusion of acute myocardial infarction in patients with cardiac complaints.
There is a pressing need for improvement of the diagnosis of acute myocardial infarction (AMI) for healthcare professionals (HCP). 1–1,5% of the population consult a physician each year with chest pain complaints. While the majority (60–80%) of these patients are sent to a hospital for further inspection, eventually AMI is diagnosed in only 8–18% of these cases. Consequently, a rapid, objective test that helps to better select patients suspected of AMI by HCPs would reduce the number of unnecessary hospital referrals and admissions, thereby saving costs and contributing to a more sustainable healthcare.

FABPulous (SME) is a medical device company spun out of Maastricht University in 2008. The core of the company is its innovative proprietary technology that allows a simple, robust and ultra-rapid diluted plasma preparation from a drop of blood. This offers great advantages over current technologies in point-of-care and home testing.

The CE-marked H-FABP True Rapid Test (H-FABP TRT) developed by FABPulous aids the HCP in ruling out AMI with a very high level of confidence. It is based on the heart-type fatty acid binding protein (H-FABP), which can be used as biomarker for AMI. With H-FABP TRT a physician is able to rule out the occurrence of an AMI for a large proportion of patients suspected of AMI. It is intended for use in both primary and emergency care.

In this project FABPulous seeks to medico-economically validate H-FABP TRT in primary (Netherlands+Belgium) and emergency care (UK) by performing two clinical trials. Outcomes of these studies lead to adoption of H-FABP TRT in medical guidelines and form the basis of a request for reimbursement towards health insurers. In this project FABPulous will improve the production process as well in order to decrease the cost price to €5 per test.

The addressable market in NW Europe alone amounts to at least 2 mln tests. The phased introduction plan leads to €8.6 mln revenue with a gross margin of €6.5 mln in 2018.