Commercialization of low cost, disposable, point-of-care molecular diagnostic device for sexually transmitted infections

Click Diagnostics开发了一种新的低成本、一次性、基于聚合酶链式反应的多路传输诊断测试 检测性传播感染(STI)衣原体、淋病和滴虫病。《中心》 疾病控制中心(CDC)估计，每年发生近2000万新的性传播感染，占几乎 160亿美元的医疗保健成本。目前的STI诊断测试主要在集中式实验室中进行， 从样本到结果到患者的平均时间为3至5天。在这段时间里，多达30%的STI阳性 患者失去了护理，并继续传播STI。其他许多人被给予不适当的药物以避免 尽管没有检测结果，但患者没有接受治疗就离开了。尽管医疗点(POC)核酸 基于放大的仪器是可用的，它们一次只能执行一项测试，这限制了它们的用途 在一家繁忙的诊所里。为了确保患者得到适当的抗生素，高度敏感和特异，负担得起， 迫切需要能够提供快速结果的POC诊断。Click患者端、一次性使用的 聚合酶链式反应(PCR)诊断测试的准确率接近100%，这将使医生能够确保 所有性传播感染的患者都会离开诊所而不接受治疗。Click已开发出样机，并成功 使用患者的临床阴道拭子样本进行了验证。在这个项目中，我们将改进设备以 实现大规模生产，并优化设备，为临床试验做准备，510(K)监管审批， 和CLIA弃权书。这将需要对产品的可制造性进行改进，执行分析前和 临床前验证和可用性研究。目标1的目标是优化试生产单元，以 可制造性和临床测试。这将需要使用低成本制造技术，最大限度地减少零件 计数以降低单位复杂性，并减小设备大小和重量。这些修改使 为目标2中的分析前和临床前试验生产设备的制造准备情况。初步 分析研究将评估设备的检测极限，并证明设备结果是可重复性的 而且很具体。Click已经与计划生育、阿拉巴马大学和约翰·霍普金斯大学建立了合作伙伴关系 大学进行临床前测试，以验证Click诊断测试。单击还将验证测试结果是否符合 罗氏金标聚合酶链式反应测定仪。这些测试将评估临床测试的准备情况，以满足 510(K)监管提交文件。所有测试都将在严格的质量控制和文件控制下进行 CLICK先进的质量管理体系。最后，在目标3中，我们将进行可用性研究，以确保 未经培训的操作员可以成功操作该设备，这是CLIA豁免所必需的。A CLIA 豁免对于Click向医生办公室和药店营销其产品至关重要。基于用户反馈， Click将对设备或书面说明进行任何必要的修改，以满足CLIA豁免 要求。这项工作的成功完成将产生一种快速的患者侧核的生产版本 基于酸的诊断设备已准备好用于临床测试。

Click Diagnostics has developed a new low-cost, disposable, PCR-based diagnostic test for multiplexed detection of the sexually transmitted infections (STI) chlamydia, gonorrhea, and trichomoniasis. The Centers for Disease Control (CDC) estimates that nearly 20 million new STIs occur every year and account for almost $16 billion in health care costs. Current STI diagnostic testing is primarily done in centralized labs with an average sample-to-result-to-patient timeline of 3 to 5 days. During this time, as many as 30% of STI-positive patients are lost to care and continue to spread the STI. Many others are given inappropriate drugs to avoid the patient leaving without treatment, despite not having test results. Although point-of-care (POC) nucleic acid amplification based instruments are available, they can perform only one test at a time, limiting their usefulness in a busy clinic. To ensure patients receive the appropriate antibiotic, a highly sensitive and specific, affordable, POC diagnostic that provides rapid results is urgently needed. The Click patient-side, single-use disposable, polymerase chain reaction (PCR) diagnostic test, with near 100% accuracy, would allow physicians to ensure no patient with an STI leaves the clinic untreated. Click has developed prototype units, and successfully validated them using clinical vaginal swab samples from patients. In this project, we will refine the device to enable mass production, and optimize the device in preparation for clinical trials, 510(k) regulatory clearance, and a CLIA waiver. This will require product refinements for manufacturability, performing preanalytical and preclinical validation, and usability studies. The goal of Aim 1 is to optimize the pre-production unit for manufacturability and clinical testing. This will require using low cost fabrication techniques, minimizing the part count to reduce unit complexity, and reducing device size and weight. These modifications enable manufacturing readiness to produce units for preanalytical and preclinical testing in Aim 2. Preliminary analytical studies will evaluate the device limit of detection and demonstrate the device results are reproducible and specific. Click has partnered with Planned Parenthood, University of Alabama, and Johns Hopkins University for preclinical testing to validate the Click diagnostic test. Click will also verify test results against a gold standard PCR instrument by Roche. These tests will assess readiness for clinical testing as required for 510(k) regulatory submission. All tests will be done under strict quality control and document control with Click’s advanced quality management system. Lastly, in Aim 3 we will conduct a usability study to ensure that untrained operators can successfully operate the device, as would be required for a CLIA waiver. A CLIA waiver is critical for Click to market its product to physician offices, and pharmacies. Based on user feedback, Click will make any necessary modifications to the device or written instructions to meet CLIA waiver requirements. Successful completion of this work will yield a production version of a rapid, patient-side nucleic acid-based diagnostic device ready for clinical testing.