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The First In Vitro Diagnostic Device for the Early Detection of Cardiac Ischemia

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A novel biomarker fills the gap in diagnosis of myocardial ischaemia

A blood test will make it possible to detect cardiac ischaemia. It will be easy to use, sensitive and cost-effective, and will support improved management of chest pain.

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Early diagnosis of ischaemia is essential to prevent progression of heart damage and tissue necrosis. The EU-funded AGLYC project has made an important contribution in this area, with the aim of reducing the disease’s impact on patients’ quality of life. Specifically, the team at sole project partner GlyCardial Diagnostics in Spain has developed an in vitro diagnostic lab-based test with high sensitivity in detecting the presence of ischaemic events. Originally named AGLYC, the test has been rebranded as iSCOR. This was just one result of the marketing strategy devised during this SME Instrument Phase 2 project, which built on the previous AGLYC Instrument Phase 1 initiative. As the website states, “iSCOR is based on the quantification of blood levels of glycosylated Apolipoprotein J (ApoJ-Glyc).” The biomarker was discovered through the analysis of serum samples of patients in the early stage of a cardiac ischaemic event that detected a decrease in the levels of ApoJ-Glyc. In its final form, iSCOR will be adapted to widely used cardiac diagnostic platforms, says project coordinator Judit Cubedo, who is also co-founder and CEO of GlyCardial Diagnostics. The solution can support many strategies for improving chest pain management.

Validation and clinical trial

The first test version has been validated in a prospective clinical trial (as part of the AGLYC project) that has confirmed its role in the early diagnosis of ischaemia and its potential prognostic role after an ischaemic event (EDICA trial). “GlyCardial has been focused on the development and validation of the novel biomarker with the final goal of sublicensing it to a diagnostic company that will bring it to the market in its final format,” Cubedo notes. Given that current biomarkers are blind for ischaemia, ApoJ-Glyc fills a gap in early detection of ischaemia before irreversible injury to the heart. “Our findings suggest that ApoJ-Glyc could be a valuable adjunct to current diagnostic tools,” Cubedo adds. This first-in-class biomarker will have a great impact on early diagnosis of an ischaemic event during emergency department triage, assessment of subclinical ischaemia and monitoring of a patient’s evolution after an ischaemic event.

Beyond the lab: from market interest to community acknowledgement

Business development activities during AGLYC included sharpening the novel biomarker’s value proposition. Project efforts have succeeded in raising interest among international experts in the field. “With all the compiled information, GlyCardial has carried out important business development activities that have revealed the interest of the cardiac diagnostic space in the novel biomarker of ischaemia that the company is developing,” Cubedo relays. In 2018, GlyCardial Diagnostics joined the EIT Health community on receipt of EIT Health Headstart funding and was a semi-finalist in its European Health Catapult programme. Just 14 months after AGLYC was launched, Cubedo was selected as a finalist for the EU Prize for Women Innovators 2020.

Keywords

AGLYC, ischaemia, biomarker, ApoJ-Glyc, heart, early diagnosis, iSCOR, necrosis, glycosylated apolipoprotein J, cardiac testing

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