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Radisens is developing a high sensitivity quantitative point-of-care in-vitro diagnostics platform – Gemini™ – to measure Ferritin (iron stores) in at-risk blood donors before they donate. A point-of-care Ferritin measurement has the advantage of early detection of iron depletion.

117 million blood donations are collected annually. Blood donors are at risk for iron depletion at a higher rate (30%) than in the general population. Specific donor subgroups are particularly at risk including frequent donors (49-66%), young adolescents (31-70%) and premenopausal women (48%). Currently a point-of-care haemoglobin test is used at pre-donation in blood donor clinics to determine if a donor is anaemic. This test cannot identify donors with low iron stores. As a result, only 8% of donors are deferred due to low haemoglobin (anaemia) which is not representative of the number of iron depleted donors.

Ferritin declines early in the development of iron deficiency, before the decline of haemoglobin. Identifying iron depleted donors post-donation is done through laboratory testing for Ferritin in at-risk donors. This donation further depletes their iron. The process does not allow for immediate face-to-face counselling; leads to longer donor deferral times; and reduces donor return rates. These at-risk groups are the most frequent donors, making up the bulk of donations. There are increasing concerns regarding the duty of care for such donors.

There is an unmet need for a ‘real-time’ point-of-care Ferritin test in donor clinics  to identify iron-depletion prior to donation. Rapid results will improve donor management by reducing donations from already iron depleted donors; enable on-the-spot counselling to better manage iron deficiency; allow for optimal deferral times; and better manage the retention of such valued donors.

Radisens is leading a €7 million grant-aided FerrTest consortium, including Trinity College Dublin, Irish Manufacturing Research and PolyPico Technologies, to complete product & process development and scale-up ahead of pre-clinical trials. Radisens seeks partner(s) to commence this project and support commercialisation of the Gemini™ Ferritin test.

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