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

白细胞免疫测试(TM)：与美国脓毒症临床专家和组织建立联系的可行性研究

• 批准号: 10020854
• 金额: $ 2.67万
• 依托单位: SEROXO LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2022
• 资助国家: 英国
• 起止时间: 2022 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=10020854
• 关键词: Leukocyte; ImmunoTest; TM; Feasibility; study

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.

败血症是人体对感染的极端反应。这是一种危及生命的医疗紧急情况，当你已经感染的感染在你的全身引发连锁反应时就会发生。在英国，败血症每年影响约25万人，导致约4.8万人死亡。早期诊断是改善临床结果的关键；然而，目前没有单一的生物标志物用于败血症的诊断，而是使用基于观察临床参数（如精神状态改变、高呼吸频率和低血压）的方法进行诊断。因此，迫切需要一种能够快速床边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，即时（POC），手指刺血测试，已在伯明翰（英国）和土耳其进行的早期临床研究中显示，这是一种潜在的改变床边败血症诊断和监测的测试。LIT监测某些白细胞的功能，现在已知在ICU脓毒症患者中有显着改变。在最近对脓毒症患者的临床研究中，我们最近发现我们测量的参数在脓毒症患者中发生了巨大的变化，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进行临床试验。这将是该公司在英国首次推出后，在美国推出长期战略的关键部分。该项目还将帮助团队建立一个在美国诊断行业工作的业务发展联系网络，为商业发布做准备，并使我们能够开始为美国的监管框架进行高层次的准备。该项目的成功将使诊断和监测这一影响全球数百万人的使人衰弱且代价高昂的疾病的床边工具得到改进。这将是Seroxo建立世界领先的临床诊断公司的关键基础，将为英国创造数十个知识密集型工作岗位，并及时为全球数百万人带来改善的临床结果。