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。这是一种威胁生命的医疗紧急情况，当您已经触发整个身体的链反应时，就会发生这种紧急情况。败血症每年影响英国约25万人，并导致约48,000人死亡。早期诊断是改善临床结果的关键。但是，目前尚无单一生物标志物用于败血症诊断，而是使用基于观察到临床参数（例如精神状态改变，高呼吸率和低血压）的方法诊断出来的。因此，迫切需要采用新颖的方法来快速的床边诊断和对败血症的监测。Seroxo开发了创新的白细胞免疫力（TM）（TM）（LIT（TM））（LIT（TM）），一种快速（10分钟），便携式，可移植的，预期的，POC）（POC）（POC），FINGER-PRIGH-PRIGHT-PRIGENS GAILSING and FURNING tORKENING tORKEY GIRKENING tHE tHE tHE tHE tHE tORKEING tHE tHE tHE tHE IRKENING tHE tHE tORKEING tHE tHE tHE tORKEY tORKEY tORKEY在公共的行为（I.测试脓毒症诊断和监测。 LIT监测某些白细胞的功能，现在已知ICU败血症患者已有显着改变。在最近对脓毒症患者的临床研究中，我们最近发现，在败血症患者中，我们测量的参数发生了巨大改变，这意味着我们将与重症监护（即ICU）和急诊科专家临床医生和关键意见领导者建立联系，以提高息际试验并开始在美国计划进行临床试验。这些将是公司在英国首次推出后在美国推出的长期策略的一部分的关键。该项目还将帮助团队建立在美国诊断行业工作的业务发展联系网络，以准备商业发射，并将使我们能够在美国开始对该项目的监管框架进行高级准备，以使该项目的良好型号和监视诊断的层次效果，并为诊断的层次而造成诊断的影响。全球。这将是Seroxo建立一家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的就业机会，并及时会改善全球数百万的临床成果。