10020854Leukocyte ImmunoTest(TM): Feasibility study to develop links with sepsis clinical experts and organisations in the USAClosedCollaborative R&DInnovate UKSepsis is the body's extreme response to an infection. It is a life-threatening medical emergency that happens when an infection you already have triggers a chain reaction throughout your body. Sepsis affects approximately 250,000 people in the UK each year and leads to approximately 48,000 deaths. Early diagnosis is key to improved clinical outcomes; however, currently no single biomarker exists for sepsis diagnosis which instead is diagnosed using a method based on observation of clinical parameters such as altered mental state, high breathing rate, and low blood pressure. Thus, there is an urgent need for novel approaches that enable rapid bedside diagnosis and monitoring of sepsis. Seroxo has developed the innovative Leukocyte ImmunoTest(tm) (LIT(tm)), a rapid (10-minute), portable, point-of-care (POC), finger-prick blood test, which has been shown in early clinical studies conducted in both Birmingham (UK) and Turkey to be a potentially game-changing test for bedside sepsis diagnosis and monitoring. The LIT monitors the function of certain white blood cells, something which is now known to be significantly altered in ICU sepsis patients. In a recent clinical study of sepsis patients we recently found the parameter we measure to be dramatically altered in sepsis patients, meaning it could be a useful marker In this project we will develop links with Critical Care (i.e., ICU) and Emergency Department specialist clinicians and Key Opinion Leaders in the USA to raise awareness and start to plan clinical trials in the US. These will be key as part of the company's long-term strategy to launch in the US after its initial launch in the UK. The project will also help the team establish a network of business development contacts working in the diagnostics industry in the USA to prepare for commercial launch and will enable us to begin high-level preparation of the regulatory framework for the USA. Success in this project will lead to an improved bedside tool for diagnosis and monitoring of this debilitating and costly condition affecting millions worldwide. It will be a key basis upon which Seroxo builds a world-leading clinical diagnostics company that will create dozens of knowledge-intensive jobs for the UK and in time will lead to improved clinical outcomes for millions around the world.