Early and accurate diagnosis of pulmonary and extrapulmonary tuberculosis in all patient groups using a circulating pathogen-derived antigen

使用循环病原体衍生抗原对所有患者组的肺结核和肺外结核进行早期准确诊断

• 批准号: 10474565
• 负责人: Thomas W Tombler
• 金额: $ 100万
• 依托单位: NANOPIN TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-25 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10474565
• 关键词: Address; Age; Antigens; Biological Assay; Blood Tests; Blood specimen; Brain; COVID-19; COVID-19 pandemic; Cause of Death; Cessation of life; Child; Childhood; Clinical; Clinical Research; Clinics and Hospitals; Cohort Studies; Communicable Diseases; Country; Data; Detection; Devices; Diagnosis; Diagnostic; Diagnostic Equipment; Diagnostic Sensitivity; Disease; Disease Outbreaks; Early Diagnosis; Enrollment; Ensure; Epidemic; Freezing; Goals; Gold; HIV; Health; Health Personnel; Healthcare Market; Individual; Infant; Infection; Kidney; Lung; Marketing; Medical center; Methods; Monitor; Outcome; Pathway interactions; Patients; Pediatric cohort; Performance; Play; Prevention; Reporting; Resource-limited setting; Resources; Role; Sampling; Shipping; Site; Sputum; Structure; System; Technology; Treatment Protocols; Tuberculosis; Tuberculosis diagnosis; United Nations; Validation; Vulnerable Populations; Work; accurate diagnosis; base; clinical diagnostics; co-infection; cohort; combat; commercialization; design; diagnostic assay; diagnostic platform; health organization; improved; innovation; mortality; pathogen; performance site; pre-clinical; rapid test; sample collection; tuberculosis diagnostics

PROJECT SUMMARY NanoPin is advancing a diagnostic for active tuberculosis (TB) that addresses critical unmet clinical needs and its innovation and potential patient impact has resulted in designation as a breakthrough device by the FDA. This device will highly valuable in the global effort to combat TB, which is now the leading cause of death from infectious disease, with an estimated 10.0 million new TB cases and 1.5 million TB-related deaths annually. Key unmet needs for TB diagnosis include a rapid test that is both culture-free and non-sputum-based, is actionable and informative especially in countries with high latent TB rates, can accurately detect both pulmonary and extrapulmonary TB, and can detect across the entire patient spectrum including young children and HIV- coinfected patients. NanoPin’s highly sensitive diagnostic platform rapidly detects species-specific TB antigens directly from blood samples. Our technology is differentiated from all current methods in that we can detect TB no matter where it is in the body and whose body it is in. We can detect TB based in the lungs, kidneys, brain and throughout the body, even when the current “gold standard” cannot. We can detect in difficult cohorts including young children and even infants and HIV co-infected, all of which are poorly served in the market and where conventional sputum methods are not feasible. Ultimately, this technology will enable health care providers to finally mitigate the enduring TB epidemic. The outcomes of successful completion of this proposal will introduce our TB diagnostic device into the market and make it available for routine use in clinics and hospitals by evaluating its performance in a well- structured clinical study in multiple high profile medical centers. We propose four specific aims: 1). To perform analytical validation of the NanoTB Assay Kit and Multiple LC-MS Platforms. Prior to initiating clinical studies, we will determine key quantitative values for the TB assay kits including LoD, LoQ, and cut-values per CLSI C62- A. We will establish multiple LC-MS platforms for clinical studies and regulatory approval which will further our commercialization reach; 2). To perform clinical studies for detection of active TB with NanoTB diagnostic assay kits. The clinical studies proposed in this aim will be the basis for 510k application to the FDA for regulatory approval and marketing of the NanoDetect-TB device. The studies will enroll patients suspected of TB disease and analyze with our TB assay and the primary AFB-culture reference method; 3). To communicate with the FDA for guidance for clinical studies and 510k submission. Interactions with the FDA will guide the efficient and successful implementation of the proposed work. The outcome of this aim is the FDA clearance of the NanoDetectTB device via the De Novo pathway; and 4). To extend clinical studies for pediatric centric and resource limited focus. We will further evaluate the critical pediatric cohort and address challenges for sample collection and handling shipping in resource limited regions in order to ensure our application can be extended to all patients.

项目概要 NanoPin 正在推进活动性结核病 (TB) 的诊断，以满足未满足的关键临床需求 其创新和潜在的患者影响已被 FDA 指定为突破性设备。 该设备对于全球抗击结核病的努力非常有价值，结核病现在是导致死亡的主要原因 传染病，估计每年新增 1000 万结核病病例和 150 万结核病相关死亡。钥匙 结核病诊断未满足的需求包括快速检测，该检测既无需培养，也无需痰液，并且具有可操作性 信息丰富，尤其是在潜伏性结核病发病率高的国家，可以准确检测肺结核和结核病 肺外结核病，并且可以检测整个患者范围，包括幼儿和艾滋病毒- 合并感染的患者。 NanoPin 的高灵敏度诊断平台可快速检测物种特异性结核病抗原 直接来自血液样本。我们的技术与当前所有方法的不同之处在于我们可以检测结核病 无论它在身体的哪个部位以及在谁的身体里。我们可以检测肺、肾、脑中的结核病 甚至在当前的“黄金标准”无法做到的情况下。我们可以在困难的群体中发现 包括幼儿甚至婴儿和艾滋病毒共同感染者，所有这些在市场上都得不到很好的服务， 传统痰方法不可行的地方。最终，这项技术将使医疗保健成为可能 提供者最终减轻持久的结核病流行。 该提案的成功完成将把我们的结核病诊断设备引入 通过评估其在良好环境中的性能，使其可在诊所和医院常规使用。 在多个知名医疗中心进行结构化临床研究。我们提出四个具体目标：1）。执行 NanoTB 检测试剂盒和多个 LC-MS 平台的分析验证。在开始临床研究之前， 我们将根据 CLSI C62 确定 TB 检测试剂盒的关键定量值，包括 LoD、LoQ 和截止值 A. 我们将建立多个用于临床研究和监管审批的 LC-MS 平台，这将进一步推进我们的业务 商业化程度； 2）。进行使用 NanoTB 诊断检测检测活动性结核病的临床研究 套件。该目标提出的临床研究将成为向 FDA 申请监管 510k 的基础 NanoDetect-TB 设备的批准和营销。该研究将招募疑似结核病患者 并使用我们的 TB 检测和主要 AFB 培养参考方法进行分析； 3）。与 FDA 指导临床研究和 510k 提交。与 FDA 的互动将指导有效和 成功实施拟议的工作。这一目标的结果是 FDA 批准了 通过 De Novo 途径的 NanoDetectTB 装置；和 4)。扩大以儿科为中心的临床研究 资源有限，重点突出。我们将进一步评估关键儿科队列并解决样本挑战 在资源有限的地区收集和处理运输，以确保我们的应用能够扩展 致所有患者。