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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - ABOPEN (FIRST INSTANT, OFF-THE-LAB AND USER-FRIENDLY BLOOD GROUPING TEST)

Teaser

Summary

Rhesus diseases of HDN (Hemolytic disease of the newborn) is caused when a woman with Rh negative blood is pregnant from a male Rh positive, having a baby Rh positive. In this case, the mother starts to produce antibodies to attack the fetal red blood cells ending with severe consequences: stillbirth, newborn death, severe jaundice and brain damage. Despite being this disease eradicated from the developed world, it still continues in much of Africa, Asia and Eastern Europe due to the lack of preventive tools and lab settings particularly in rural areas (e.g. around 300,000 cases are reported annually in these regions). Since this disease can be easily eliminated by screening the Rh group of pregnant women and prophylaxis (if it is needed), we have developed ABOPEN (renamed as Rhesus Stick) a user-friendly off-the-lab test to identify the RhD factor type in just 1 minute and a single-step procedure. The device can be stored for up to 24 months at 37ÂºC, can be used by anyone in anywhere (at home, clinics, rural dispensaries) and have a fair priced (â‚¬4), which represents a good opportunity to be adopted as women Rh screening routine in developing countries.

Work performed

The Feasibility Study performed has focused on 4 main areas. From a technical point of view, we have redesigned the device for obtaining an optimized prototype, outlined the roadmap product development and the scale up process assessing the best strategy keeping the final product at a price of â‚¬4. On the clinical side, we have designed a multicenter study to ensure ABOPEN accurate performance. Commercially, we have performed an analysis of the blood typing market, and prepared a data base of the most relevant NGOs operating in developing countries. We have revised our IP strategy including a Freedom-to-operate and analyzed the regulatory requirements for CE marking and FDA approval. Finally, on the economic side, we have built financial forecast for the next 5 years, based on the best business model and pricing strategies.

Final results

Once in the market, ABOPEN will contribute to eradicate the devastating problem of HDN easing the access to Rh screening in low resources setting, saving 90,000 neonatal lives and eliminating 48,000 cases of babies with brain damages occurring annually in developing countries.