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 此CRP SBIR项目旨在向市场推出一种护理点(POC)测试来测量患者 坚持暴露前预防(PrEP)作为预防HIV感染的已知人群 面临艾滋病毒暴露的风险，并接受抗逆转录病毒疗法(ART)作为艾滋病毒的治疗。艾滋病毒对 全球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在预防艾滋病毒感染方面有99%的有效率，但依从性很差。建议使用Prep 美国疾病控制与预防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，以及血清不一致的夫妇。同样，ART可以有效地抑制病毒载量 在遵循剂量计划的情况下。由于依从性差，不仅患者得到不适当的治疗， 产生耐药菌株的机会增加了。众所周知，药物依从性监测可以改善药物 合规性，但目前还没有商业产品用于快速监测PrEP和 艺术。为了被患者接受并在医生工作流程中可行，这种依从性测试需要 无创、无痛、价格低廉、易于管理并提供快速、准确的结果。The UrSure The UrSure 快速替诺福韦POC试验测量替诺福韦(TFV)，它是PrEP的一种成分，也是ART的90% 养生法。这个项目已经成功地完成了第一阶段，在那里我们证明了这一点的可行性 接近。合成了一种新的TFV衍生物，并将其用于生产新型抗TFV抗体。 对TFV具有特异性和敏感性。在第二阶段第一年，我们成功地开发出了100%灵敏度的原型 和100%的特异性，目前处于第二阶段和第二年，验证LFIA的性能以启动技术 转给我们的合同制造商。PoC测试无创、无痛、快速(只需几分钟即可得到结果) 价格也不贵。它可以在诊所就诊时用来衡量PrEP的遵从性，如果合适的话，还可以用来评估咨询 如何提高患者的依从性。 为了能够为商业化的UrSure泰诺福韦快速测试做准备，我们正在寻求参与 在一个CRP项目中。此CRP项目的目标是进行所需的所有验证研究 监管流程，使我们的设备获得全球市场批准。其目的是：1)评估 扩大化验的批内和批间验证和重复性；2)进行分析性验证研究 对于FDA 510k提交，以及3)进行并提交FLEX研究以获得CLIA豁免。UrSure有 与在监管流程方面有丰富经验的专家和组织建立了适当的关系，特别是在 诊断和医疗设备。此CRP项目的最终交付成果将经过验证和扩展 制造流程和申请以获得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等待验证的原型 在全球范围内进行商业发布。

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.