10006719Creation of a novel monitoring tool to predict abnormal coagulation in COVID-19.ClosedResponsive Strategy and PlanningInnovate UKThe formation of blood clots has been identified as a potential risk factor for a very small proportion of individuals receiving certain types of COVID-19 vaccine. A larger proportion of people who have tested positive for COVID-19 (the infectious disease caused by the coronavirus) have also experienced inappropriate blood clotting, which has resulted in more severe symptoms and unfortunately, been associated with a higher risk of virus-related death. ProAxsis is a Belfast-based company, specialising in the measurement of a group of enzymes called proteases. Increased levels of two of this group of enzymes, thrombin and factor-Xa, has been linked to the fact that some people may have an increased chance of developing blood clots. These blood clots can lead to severe health problems including strokes or organ failure. Pharmaceutical companies who are producing COVID-19 vaccines or developing new drugs to treat COVID-19 patients therefore need to find a reliable method of measuring these proteases so that "at risk" patients can be identified early and treated appropriately. In this project, ProAxsis will use its long-standing and unique expertise in the chemistry of proteases and _in vitro_ diagnostic development to create a brand new combination laboratory test. This test will measure the two key protease biomarkers, thrombin and factor-Xa, at the same time in a clinical sample, using an automated procedure known as multiplexing. ProAxsis has the team in place, and the extensive experience required, to very rapidly create and then up-scale a combination multiplex test for these highly important protease targets. Aside from providing key insights as to why certain vaccines may lead to increased rates of blood clots, this project offers substantial benefits to the patients affected by the COVID-19 virus, the healthcare professional teams providing them with clinical care, and the pharmaceutical companies developing new or repurposed drugs for treating the virus. In turn, this will support healthcare systems such as the UK's National Health Service (NHS) to decide which vaccines and drugs they should prioritise to purchase from their limited budgets, and identify which patients are most likely to respond to the new range of drugs expected to be available. This project specifically focuses on addressing the needs associated with COVID-19 vaccination and treatment, but in the future, this newly developed test could also benefit the large number of people with other conditions caused by increased blood clotting, such as strokes and heart attacks.