A Point of Care Test to Monitor and Promote Adherence to Tenofovir-based regimens for the Prevention and Treatment of HIV

用于监测和促进对基于替诺福韦的艾滋病毒预防和治疗方案的依从性的护理测试

基本信息

批准号：
10011595
负责人：
Giffin Daughtridge
金额：
$ 93.37万
依托单位：
URSURE, INC.
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-06-09 至 2021-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10011595
关键词：
AIDS prevention AIDS/HIV problem Address Adherence Antibodies Bedside Testings Biological Assay Centers for Disease Control and Prevention (U.S.)Cessation of life Clinic Visits Contracts Counseling Couples Dangerousness Development Devices Diagnostic Diagnostic tests Disease Dose Drug Monitoring Ensure Equipment Exposure to Goals Grant Guidelines HIV HIV Infections HIV Seropositivity HIV therapy Hand Health Health Care Costs Immunoassay Infection Lateral Liquid Chromatography Manufacturer Name Measures Medical Device Methods Monitor Nature Outcome Painless Patients Performance Pharmaceutical Preparations Phase Physicians Population Prevalence Prevention Prevention therapy Procedures Process Provider Public Health Readiness Regimen Reporting Reproducibility Resources Risk Schedule Sensitivity and Specificity Shipping Small Business Innovation Research Grant Specificity Specimen Handling Technology Transfer Tenofovir Test Result Testing Urine Validation Viral Load result antiretroviral therapy base commercialization compliance behavior cost experience high risk improved innovation intravenous drug user manufacturing process manufacturing scale-up medication compliance men who have sex with men novel point of care portability pre-exposure prophylaxis prevent programs prototype resistant strain scale up success tandem mass spectrometry validation studies waiver

项目摘要

PROJECT ABSTRACT This CRP SBIR project aims to launch to market a point-of-care (POC) test to measure patient adherence to Pre-exposure Prophylaxis (PrEP) as a prevention against HIV infection in people known to be at risk of HIV exposure, and to antiretroviral therapy (ART) as treatment to HIV. HIV contributes to millions of infections and deaths per year and tens of billions of dollars in healthcare costs around the world. PrEP is 99% effective at preventing HIV infection if taken daily, but adherence in poor. PrEP is recommended by the CDC in populations at a high risk of HIV infection, which include men who have sex with men, intravenous drug users, and serodiscordant couples. Similarly, ART, can be effective and suppress viral load when following the dosing schedule. Due to poor adherence, not only are patients inappropriately treated, the chance of developing resistant strains is increased. Drug adherence monitoring is well known to improve drug compliance, but currently there are no commercial products for rapid adherence monitoring of PrEP and ART. To be acceptable to patients and feasible in the physician workflow, this adherence test needs to be non-invasive, painless, inexpensive, easy to administer and provide rapid, accurate results. The UrSure Rapid Tenofovir POC test measures tenofovir (TFV), which is a component of PrEP and 90% of ART regimens. This project has successful completed Phase I where we demonstrated the feasibility of this approach. A novel TFV derivative was synthesized and used to produce novel anti-TFV antibodies that are specific and sensitive for TFV. In Phase II Year 1, we successfully developed a prototype with 100% sensitivity and 100% specificity and are currently in Phase II Year 2 verifying the LFIA performance to initiate technology transfer to our contract manufacturer. The POC test is noninvasive, painless, rapid (minutes to get a result) and inexpensive. It can be used during a clinic visit to measure PrEP adherence and, if appropriate, counsel patients on how to improve compliance. To be able to prepare the UrSure Tenofovir Rapid Test for commercialization, we are looking to engage in a CRP project. The objective of this CRP project is to conduct all validation studies required for the regulatory processes to allow our device to gain market approval globally. The Aims are to: 1) Evaluate intra and inter-lot validation and reproducibility of the scaled-up assay, 2) Conduct analytical validation studies for a FDA 510k submission, and 3) Conduct and submit flex studies to obtain CLIA-waiver. UrSure has relationships in place with experts and organizations with deep experience in regulatory process, especially in the diagnostics and medical devices. The final deliverables of this CRP project will be validated and scale-up manufacturing process, and submissions to obtain FDA pre-market approval, CLIA-waiver, and CE Mark approval. Successful completion of this CRP project will result in a validated prototype awaiting commercial launch globally.

项目摘要该 CRP SBIR 项目旨在向市场推出一种即时检测 (POC) 测试来测量患者的情况坚持暴露前预防 (PrEP) 作为已知人群预防 HIV 感染的措施存在暴露于 HIV 的风险，并接受抗逆转录病毒治疗 (ART) 作为 HIV 治疗方法。艾滋病毒有助于全世界每年有数百万人感染和死亡，医疗费用高达数百亿美元。如果每天服用，PrEP 预防 HIV 感染的有效率为 99%，但依从性较差。建议进行 PrEP 疾病预防控制中心对艾滋病毒感染高危人群进行了调查，其中包括男男性行为者，静脉注射吸毒者和血清不一致的夫妇。同样，ART 可以有效抑制病毒载量当遵循给药方案时。由于依从性差，不仅患者得不到适当的治疗，产生耐药菌株的机会增加。药物依从性监测众所周知可以改善药物合规性，但目前还没有用于快速监测 PrEP 依从性的商业产品艺术。为了让患者能够接受并且在医生工作流程中可行，这种依从性测试需要非侵入性、无痛、廉价、易于管理并提供快速、准确的结果。乌苏尔快速替诺福韦 POC 测试可测量替诺福韦 (TFV)，它是 PrEP 和 90% ART 的组成部分治疗方案。该项目已成功完成第一阶段，我们证明了该项目的可行性方法。合成了一种新型 TFV 衍生物并用于生产新型抗 TFV 抗体对 TFV 具有特异性和敏感性。在第二阶段第一年，我们成功开发了灵敏度为 100% 的原型和 100% 特异性，目前正处于第二阶段第二年验证 LFIA 性能以启动技术转移给我们的合同制造商。 POC 测试无创、无痛、快速（几分钟即可得出结果）而且价格便宜。它可以在诊所就诊期间用于衡量 PrEP 依从性，并在适当情况下提供建议患者如何提高依从性。为了能够准备 UrSure 替诺福韦快速测试的商业化，我们正在寻求参与在 CRP 项目中。该 CRP 项目的目标是进行所有所需的验证研究监管流程，使我们的设备获得全球市场的批准。目标是： 1) 评估放大试验的批内和批间验证以及再现性，2) 进行分析验证研究 FDA 510k 提交，以及 3) 进行并提交弹性研究以获得 CLIA 豁免。优素有与在监管流程方面拥有丰富经验的专家和组织建立了关系，特别是在诊断和医疗设备。该 CRP 项目的最终交付成果将得到验证并扩大规模制造工艺以及获得 FDA 上市前批准、CLIA 豁免和 CE 标志的提交赞同。该 CRP 项目的成功完成将产生一个等待验证的原型全球商业启动。