Handheld Micro-Laboratory to Enable Ambulant Multi-Parameter Blood Coagulation Analysis

Hemophilia is a rare genetic disorder that is estimated to affect over 800,000 people worldwide. Those with hemophilia A lack sufficient blood- clotting factor VIII (FVIII) activity, causing them to bleed for longer after an injury compared to healthy subjects. Due to the complexities associated with managing the condition, patients benefit from being able to safely monitor their condition at home while potentially staying connected with their care team by telemedicine. Now, a breakthrough ambulant diagnostic technology for blood coagulation testing will enable hemophilia patients to determine and monitor their coagulation status from home in real-time.

Enzyre B.V. (Nijmegen, The Netherlands) is developing its unique diagnostic technology platform, EnzyPad, which will enable hemophilia patients to self-test in a home setting, and eventually transfer their coagulation status to their treating physician through a mobile phone app and a cloud- based application. This will allow for timely personalized therapy adjustments that may improve clinical outcomes while avoiding unnecessary travel and hospital exposure, ultimately decreasing overall treatment burden and cost for patients and healthcare systems.

EnzyPad has only four components: blood sampling device (TAP in case of haemophilia), microfluidic cartridge (EnzyCard), processor (EnzyPad) and a mobile phone with the ENZY app. As it is the size of a small tablet, EnzyPad is easily portable and fits into a small backpack together with several EnzyCards. Each EnzyCard contains reagents and appropriate controls to perform several coagulation tests in parallel on a single blood sample. The results have the same quality as if performed on a large instrument in a specialized laboratory and are available in real-time right next to the patient who can get the optimal therapy without any delay.

In order to find the cause of a bleed, in most cases it is necessary to determine several parameters simultaneously. As a single EnzyCard can handle up to sixteen tests in parallel, there is ample space for multiple assays and corresponding controls. The EnzyPad will encrypt the data of the test results and transfer them via a Bluetooth connection to a mobile phone app, that will place the data in the cloud where anyone with the appropriate credentials can access them. The first EnzyPad products will be focused on blood coagulation, although the technology can be applied much more broadly in collaboration with partners that have expertise in different fields.

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Enzyre B.V.

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