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

用于性传播感染的低成本一次性护理点分子诊断设备的商业化

• 批准号: 9547262
• 负责人: GREGORY C LONEY
• 金额: $ 46.76万
• 依托单位: VISBY MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-18 至 2019-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9547262
• 关键词: Affect; Alabama; Antibiotic Resistance; Antibiotics; Biological Assay; Businesses; Caring; Centers for Disease Control and Prevention (U.S.); Chlamydia; Chlamydia Infections; Chlamydia trachomatis; Clinic; Clinical; Clinical Research; Clinical Trials; Current Procedural Terminology Codes; Data; Detection; Developing Countries; Devices; Diagnostic; Diagnostic tests; Disease; Ectopic Pregnancy; Ensure; Feedback; Future; Goals; Gold; Gonorrhea; Health Care Costs; Home environment; Infection; Infertility; Instruction; Insurance; Left; Location; Medical; Military Personnel; Mission; Modification; Molecular Diagnostic Testing; Neisseria gonorrhoeae; Nosocomial Infections; Nucleic Acids; Patients; Pelvic Inflammatory Disease; Performance; Pharmaceutical Preparations; Pharmacy facility; Physicians; Physicians' Offices; Planned Parenthood Federation of America; Polymerase Chain Reaction; Preclinical Testing; Preparation; Price; Production; Provider; Quality Control; Readiness; Reporting; Reproducibility; Reproducibility of Results; Reproductive system; Respiratory Tract Infections; Risk; Running; Sampling; Sensitivity and Specificity; Sexually Transmitted Diseases; Side; Site; Swab; System; Techniques; Test Result; Testing; Time; TimeLine; Training; Trichomonas Infections; Trichomonas vaginalis; United States; Universities; Urine; Vagina; Validation; Weight; Work; base; biothreat; commercialization; cost; cross reactivity; improved; instrument; manufacturability; miniaturize; molecular diagnostics; multiplex detection; point of care; point-of-care diagnostics; pre-clinical; preclinical study; prevent; prototype; research clinical testing; success; usability; validation studies; waiver

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.

Click Diagnostics开发了一种新的低成本，一次性，基于PCR的诊断测试，用于多重 检测性传播感染（STI）衣原体、淋病和滴虫病。中心 美国疾病控制中心（CDC）估计，每年有近2000万例新的性传播感染发生， 160亿美元的医疗费用。目前的STI诊断测试主要在集中实验室进行， 从样本到结果到患者的平均时间轴为3 - 5天。在此期间，多达30%的性传播感染阳性 病人得不到照顾，继续传播性传播感染。还有许多人服用了不适当的药物来避免 病人没有治疗就离开了，尽管没有检查结果。尽管即时（POC）核酸 基于放大的仪器是可用的，它们一次只能执行一个测试，限制了它们的有用性 在一个繁忙的忙碌诊所。为了确保患者获得适当的抗生素，一种高度敏感和特异性的，负担得起的， 迫切需要提供快速结果的POC诊断。Click患者侧，一次性使用， 聚合酶链反应（PCR）诊断测试的准确率接近100%，将允许医生确保 没有一个感染性病的病人离开诊所而不接受治疗。Click开发了原型装置，并成功地 使用患者的临床阴道拭子样本验证它们。在这个项目中，我们将改进设备， 实现大规模生产，并优化器械，为临床试验、510（k）监管许可做准备， 还有CLIA的弃权书这将需要产品的可制造性，进行预分析和 临床前验证和可用性研究。目标1的目标是优化预生产单元， 可制造性和临床测试。这将需要使用低成本的制造技术，最大限度地减少部分 计数，以减少单位的复杂性，并减少设备的大小和重量。这些修改使 为目标2中的分析前和临床前试验生产单元的生产准备就绪。初步 分析研究将评价器械的检测限，并证明器械结果具有重现性 和具体。Click与计划生育、亚拉巴马大学和约翰霍普金斯大学合作 临床前测试，以验证点击诊断测试。Click还将根据 金标准PCR仪。这些测试将评估临床测试的准备情况， 510（k）注册申报。所有测试将在严格的质量控制和文件控制下进行， 点击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器械，这是CLIA豁免所要求的。A CLIA 豁免对于Click向医生办公室和药房销售其产品至关重要。根据用户反馈， Click将对器械或书面说明进行任何必要的修改，以满足CLIA豁免要求 要求.这项工作的成功完成将产生一个生产版本的快速，病人侧核酸 酸为基础的诊断设备准备临床测试。