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

项目摘要 该CRP SBIR项目旨在向市场推出一种即时（POC）检测，以测量患者 坚持暴露前预防（PrEP）作为预防艾滋病毒感染的已知人群 艾滋病毒感染风险，以及抗逆转录病毒疗法（ART）治疗艾滋病毒。艾滋病毒有助于 每年有数百万人感染和死亡，全世界的医疗保健费用高达数百亿美元。 如果每天服用，PrEP在预防艾滋病毒感染方面的有效性为99%，但坚持性较差。建议使用PrEP 疾病预防控制中心在艾滋病毒感染高危人群中，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，不仅患者治疗不当， 增加了产生耐药菌株的机会。药物依从性监测是众所周知的，以改善药物治疗。 合规性，但目前还没有用于PrEP快速依从性监测的商业产品， 条为了让患者接受并在医生工作流程中可行，需要对该依从性测试进行 非侵入性、无痛、廉价、易于管理并提供快速、准确的结果。UrSure 快速替诺福韦POC测试测量替诺福韦（TFV），它是PrEP的一个组成部分，也是ART的90% 养生法该项目已成功完成第一阶段，我们证明了这一点的可行性 approach.合成新型TFV衍生物并用于产生新型抗TFV抗体， 对TFV具有特异性和敏感性。在第二阶段的第一年，我们成功地开发了一个原型，具有100%的灵敏度 和100%的特异性，目前正在第二阶段第二年验证LFIA性能，以启动技术 转移到我们的合同制造商。POC测试是无创的，无痛的，快速的（几分钟就能得到结果） 而且便宜。它可以在诊所访问期间使用，以衡量PrEP的依从性，如果合适的话， 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。本CRP项目的目标是进行所有所需的验证研究， 监管流程，以使我们的设备在全球获得市场批准。目的是：（1）评估 放大试验的批内和批间验证和重现性，2）进行分析验证研究 用于FDA 510k提交，以及3）进行并提交弹性研究以获得CLIA豁免。UrSure拥有 与在监管过程中具有丰富经验的专家和组织建立关系，特别是在 诊断和医疗设备。将验证和扩大该CRP项目的最终交付成果 制造工艺，并提交申请以获得FDA上市前批准、CLIA豁免和CE标志 批准该CRP项目的成功完成将导致一个经过验证的原型等待 全球范围内的商业发射。

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.