Project description
A novel biomarker for cardiac ischaemia
Restriction of blood supply to the heart causes the phenomenon of myocardial ischaemia and can lead to tissue damage, significantly impacting the heart’s ability to pump blood. However, there are no biomarkers to detect cardiac ischaemia early on. The EU-funded AGLYC project has developed an in vitro diagnostic device that measures the blood levels of glycosylated Apolipoprotein J as a biomarker for cardiac ischaemia. The test relies on the fact that in patients with acute myocardial infarction, the glycosylation pattern of Apolipoprotein J changes. Implementation of the test in clinical practice will offer doctors the opportunity to detect ischaemia within 30 minutes after onset and commence on the appropriate treatment.
Objective
Cardiovascular diseases (CVD) are the leading cause of death/morbidity across the globe, accounting for 31% of all deaths in 2015.
Early detection of ischemia (restriction in blood supply to tissues, causing oxygen shortage) is essential to prevent the progression of heart damage, but right now, we don’t have any biomarkers for the early detection of cardiac ischemia. In fact, almost 90% of the available in vitro diagnostic (IVD) methods are based on the quantification of markers of necrosis, an advanced stage of organ damage. Obviously, these methods are useless for the early detection of ischemic damage.
AGLYC is an IVD device based on the rapid quantification circulating plasma Apo J-Glyc levels as a novel biomarker for the diagnosis, prognosis and risk stratification of ischemia and ischemic tissue damage. AGLYC demonstrates a 97% sensitivity in detecting the presence of cardiac ischemia; market state of the art is 39%. It also detects ischemic damage at an early and reversible phase (30 min after ischemia onset); state of the art can only detect ischemia 6 hrs after its onset when tissue damage is irreversible. We are currently at TRL6 having the competitive advantages of high sensitivity, early detection and cost effectiveness.
The Global IVD market accounted for $61,103M in 2016 and is estimated to reach $84,647M by 2023, growing at a CAGR of 4.6% from 2017-2023. We have estimated a lab-based target market of >70M patients (USA+5EU) and a Point of Care (POC) target market of >36M patients (USA+5EU). Our main business model will be a sublicense model: a lab-based test will be developed and sublicensed to either a medical device company (like MedTech) or to a pharmaceutical company for the co-development and commercialization of the POC device. GlyCardial Diagnostics, S.L. is a small company of 4 (3 women, 1 man) but with the successful completion of the SMEI Phase 1 and 2 we estimate an EBITDA of around €19M, creating 10 new jobs by 2024.
Fields of science
Programme(s)
Funding Scheme
SME-1 - SME instrument phase 1Coordinator
08028 BARCELONA
Spain
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.