Horizon 2020 SME
August
Cracking the chest pain problem

FABPulous develops and markets pioneering solutions for better diagnostics in primary care and emergency medicine

More than six out of 10 people referred for observation when complaining of chest pains are unnecessarily admitted to hospital in the UK because Emergency Department (ED) staff do not have the diagnostic tools to confidently decide if a patient is at risk of having suffered a potentially fatal heart attack before the clinical deadline for admissions.

Diagnostic solutions company FABPulous has developed a five-minute biomarker test designed to detect heart-type Fatty Acid Binding Protein (H-FABP), which swiftly appears in capillary blood after a heart attack.

The patented finger prick H-FABP True Rapid Test® developed by FABPulous, founded by Jan Glatz, Professor of Cardiac Metabolism at the Cardiovascular Research Institute Maastricht (CARIM) Maastricht University, could help slash waiting times, free up hospital beds and drastically cut costs for healthcare providers by reducing the number of unnecessary admissions of chest pain sufferers who are not at risk of Acute Myocardial Infarction (heart attack).

When is chest pain a heart attack?

The process of risk stratification when identifying which patients that require urgent care has been in common medical practice for many years. But the predictive accuracy of many risk assessment tools is modest. GP or ED doctors often lack the real time diagnostic tests that would help them decide whether symptoms similar to a life threatening condition are in fact caused by common and relatively benign problems such as gastric reflux or panic attacks.

Tests, including ECG and blood levels of cardiac proteins such as troponin, indicate that heart muscle has been injured. However, these blood tests take time to perform, turn-around time for laboratory tests from a hospital laboratory typically takes 90 minutes to report back to the ED doctor and usually overnight for a GP.

So the doctor has to use medical judgement based on ECG, symptoms and experience and since the risk of missing a heart attack victim are high, a doctor will often refer patients to ED and from there admit to overnight observation.

For example, of the 412,000 patients diagnosed as possible Acute Coronary Syndrome (ACS) cases by ED in the UK during 2012, 275,000 patients were admitted of which approximately 65% were eventually discharged with a diagnosis other than ACS, spending on average 1.3 days in hospital.

Prof Glatz was the first to describe H-FABP as a post-graduate student in 1983 and founded FABPulous as a spin-off from Maastricht University at the end of 2008. The company closed a first equity financing round co-led by Thuja Capital, Health Innovations, Limburg Ventures and NV Industriebank LIOF in December 2009.

Solving the dilemma

Over the following four years, FABPulous Chief Technology Officer Diederik Engbersen led the development of the finger prick test that takes just 5 minutes to provide a result, does not require equipment, is simple to use and easy to interpret.

The result, H-FABP True Rapid Test®, was CE marked in 2013 and has since received 13 patents. In 2014 the first of several publications on the characteristics of the test were published.

However, three barriers stand between development and general medical use on patients thought to be at risk of Acute Myocardial Infarction (AMI).

More clinical evidence is required to prove that H-FABP True Rapid Test® is a reliable way to “Rule Out” ACS. Investment was also needed to automate the manufacturing process and provide a Healthcare Economic Study analysing the relative value to patients, the healthcare system and society.

Horizon 2020 SME Instrument

Estimated costs of nearly €2m to achieve these aims is beyond the financial resources of innovative start up organisations; so in October 2014, FABPulous submitted an application for support from the new SME Instrument of the EU’s Horizon 2020 Framework Programme for Research and Innovation.

FABPulous was delighted to be notified in December 2014 that it would be awarded an exceptional 100% contribution grant for €1.63m to fund clinical trials for use of H-FABP at point of care with the Manchester Acute Coronary Syndromes (MACS) protocol in the Emergency Department; to complete its RAPIDA study in Belgium and The Netherlands and to begin the process of automation.

The RAPIDA Study

In the RAPIDA (RAPid test for Investigating complaints possibly Due to Acute coronary syndrome) study, Principal Investigator, Dr Robert Willemsen, will recruit 600 patients for an external validation study to identify signs and symptoms that, combined with point of care H-FABP testing, can be part of an algorithm to either confirm or rule out ACS.

The H-FABPulous Study

In countries where emergency medicine is based on the Anglo-American model, 98% of patients that will be diagnosed with ACS can be identified and sent to cardiology using the Manchester ACS protocol within the first 3 hours. In diagnosis of the last 2% of sufferers, however, 2/3rds of low risk patients will be admitted for observation overnight.

Professor Rick Body from Central Manchester University Hospitals NHS Foundation Trust, proposes with his protocol that a point of care test for H-FABP three hours after entry into A&E will identify 80-90% of the remaining ACS sufferers allowing the safe discharge of those patients that show no symptoms or diagnostic results with a high level of prediction, above 99.5%. With the help of the Horizon 2020 grant, 1,550 (1500-1700) patients will be recruited from 8 UK and 2 Dutch Emergency Departments, offering the statistical sensitivity required to provide the confidence that changes medical practice. The trial will be accompanied by a Healthcare Economic Study conducted by Dr Yaling Yang, supported by the Diagnostic Evaluation Collaborative based in the Department of Primary Care of Oxford University.

With the clinical trials now in process and the healthcare economic studies in design, FABPulous is busy establishing its commercial infrastructure, sited at FABPulous Ltd in Cambridge, England. The company will have completed the necessary Quality Management System certification and be prepared to sell, supply and support the use of H-FABP True Rapid Test by the commercial launch by the end of 2016.