An innovative system for diagnosing tuberculosis in children

诊断儿童结核病的创新系统

• 批准号: 49934
• 金额: $ 8.47万
• 依托单位: TIKA DIAGNOSTICS LIMITED
• 依托单位国家: 英国
• 项目类别: Study
• 财政年份: 2020
• 资助国家: 英国
• 起止时间: 2020 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=49934
• 关键词: innovative; system; diagnosing; tuberculosis; children

A quarter of the world's population are already latently infected with Mycobacterium tuberculosis (MTB). In 2018 the WHO reported 1.1 million children became ill with TB leading to 205,000 child deaths. Accurate diagnosis is critical to deliver effective treatments, limit spread and support global eradication.There are several TB diagnostic test types - radiographic methods, culture methods, nucleic acid testing, phage assay, cytokine detection test, detection of drug resistance, and Mantoux test. Culture methods remains the gold standard for confirmation of diagnosis and determination of full antibiotic resistance patterns.Unfortunately, in children, 40% of lung TB cases have such low MTB numbers present that culture confirmation is never achieved. Improved culture diagnostic tests are urgently needed.Tika is developing a game changing TB diagnostic culture enhancement kit that uniquely increases the capability of Mycobacterium tuberculosis (MTB) to grow, be detected and typed for antibiotic resistance in conventional media. The kit also offers a novel method for sample preparation from faeces that will transform sample collection from children, enabling much higher detection rates without the distress of current techniques. Nothing like this currently exists in the market.WHO estimates 60 million TB tests including 3-4 million MTB culture tests are performed annually. Culture based tests lead the TB diagnostics market and this is likely to continue on account of the ability to accurately diagnose and confirm active tuberculosis. (Transparency Market Research). The market segment for MTB culture is $600 million and estimated to grow by 4% CAGR over the next 4 years. WHO is applying pressure on the market through their global "End TB" strategy.Tika has a world leading team of TB experts developing the products, with a clear roadmap to take them to market. The outputs of this project will guide product development, support further development of the business plan / routes to market, and underpin the raising funds to finance the development. The project provides excellent value for money, both economically and for patients.

世界上四分之一的人口已经潜伏感染结核分枝杆菌（MTB）。2018年，世卫组织报告称，110万儿童患结核病，导致20.5万儿童死亡。准确的诊断对于提供有效的治疗、限制传播和支持全球根除至关重要。结核病诊断测试有几种类型-放射学方法、培养方法、核酸测试、噬菌体测定、细胞因子检测测试、耐药性检测和Mantoux测试。培养方法仍然是确认诊断和确定完整抗生素耐药性模式的金标准。不幸的是，在儿童中，40%的肺结核病例中存在如此低的MTB数量，以至于从未实现培养确认。Tika正在开发一种改变游戏规则的结核病诊断培养增强试剂盒，该试剂盒独特地提高了结核分枝杆菌（MTB）在常规培养基中生长、检测和分型抗生素耐药性的能力。该试剂盒还提供了一种从粪便中制备样本的新方法，这将改变儿童样本的收集方式，从而实现更高的检测率，而不会受到当前技术的困扰。世卫组织估计，每年进行6000万次结核病检测，包括300 - 400万次结核分枝杆菌培养检测。基于培养的检测引领结核病诊断市场，由于能够准确诊断和确认活动性结核病，这种情况可能会继续下去。（透明市场研究）。MTB文化的细分市场为6亿美元，预计未来4年将以4%的复合年增长率增长。世卫组织正在通过其全球“终结结核病”战略对市场施加压力。Tika拥有一个世界领先的结核病专家团队开发产品，并制定了将产品推向市场的明确路线图。该项目的产出将指导产品开发，支持进一步制定业务计划/市场路线，并支持筹集资金为开发提供资金。该项目在经济上和病人身上都物有所值。