Leukocyte ImmunoTest(TM): Feasibility study to develop links with sepsis clinical experts and organisations in the USA

败血症是身体对感染的极端反应。这是一种危及生命的紧急医疗事件，当你已经感染的病毒在你全身引发连锁反应时就会发生。在英国，败血症每年影响大约250,000人，并导致大约48,000人死亡。早期诊断是改善临床结果的关键；然而，目前还没有单一的生物标志物用于脓毒症的诊断，相反，通过观察临床参数(如精神状态改变、呼吸频率高和低血压)来诊断败血症。因此，迫切需要能够实现床边快速诊断和监测败血症的新方法。Seroxo开发了创新的白细胞免疫测试(LIT(Tm))，这是一种快速(10分钟)、便携式、指尖抽血测试，在英国伯明翰和土耳其进行的早期临床研究表明，这可能是一种改变床边败血症诊断和监测游戏规则的测试。LIT监测某些白细胞的功能，现在已知在ICU脓毒症患者中这种功能发生了显著变化。在我们最近对脓毒症患者进行的一项临床研究中，我们发现我们测量的参数在脓毒症患者中发生了显著变化，这意味着它可能是一个有用的标记，在这个项目中，我们将与美国的重症监护(即ICU)和急诊科专家临床医生和关键意见领袖建立联系，以提高认识并开始计划在美国的临床试验。作为该公司在英国推出后在美国推出的长期战略的一部分，这些将是关键。该项目还将帮助该团队建立一个在美国诊断行业工作的业务发展联系人网络，为商业推出做准备，并使我们能够开始高水平地准备美国的监管框架。该项目的成功将带来改进的床边工具，用于诊断和监测这种影响全球数百万人的虚弱和昂贵的疾病。这将是Seroxo打造世界领先的临床诊断公司的关键基础，该公司将为英国创造数十个知识密集型工作岗位，最终将改善世界各地数百万人的临床结果。

Sepsis 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 markerIn 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.