Descrizione del progetto
Un nuovo biomarcatore per l’ischemia cardiaca
La riduzione dell’afflusso di sangue al cuore provoca il fenomeno dell’ischemia miocardica e può causare danni ai tessuti, con impatti significativi sulla capacità del cuore di pompare il sangue. Tuttavia, non esistono biomarcatori per rilevare in anticipo l’ischemia cardiaca. Il progetto AGLYC, finanziato dall’UE, ha sviluppato un dispositivo diagnostico in vitro che misura i livelli ematici dell’apolipoproteina glicosilata J come biomarcatore per l’ischemia cardiaca. Il test si basa sul fatto che, nei pazienti con infarto del miocardio acuto, lo schema di glicosilazione dell’apolipoproteina J cambia. L’adozione di questo test nella pratica clinica fornirà ai medici la possibilità di rilevare un’ischemia entro 30 minuti dall’insorgenza e di avviare il trattamento idoneo.
Obiettivo
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.
Campo scientifico
Programma(i)
Argomento(i)
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-SMEInst-2018-2020-1
Meccanismo di finanziamento
SME-1 - SME instrument phase 1Coordinatore
08028 BARCELONA
Spagna
L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione.