Development and Commercialization of an Innovative Rapid HIV-1 Incidence Assay

创新型 HIV-1 发病率快速检测方法的开发和商业化

• 批准号: 9315110
• 负责人: Ronald William Mink
• 金额: $ 79.15万
• 依托单位: SEDIA BIOSCIENCES CORPORATION
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-05 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9315110
• 关键词: Address; Africa; Area; Asia; Biological Assay; Biological Sciences; Blood; Blood Specimen Collection; Blood specimen; Centers for Disease Control and Prevention (U.S.); Characteristics; Clinical; Clinical Management; Clinical Trials; Cold Chains; Complex; Consensus; Contact Tracing; Counseling; Critical Pathways; Data; Developing Countries; Development; Diagnosis; Diagnostic; Disease; Effectiveness of Interventions; Environment; Epidemic; Epidemiologist; Evaluation; Funding; Gold; Government; HIV; HIV Infections; HIV-1; Hot Spot; Human immunodeficiency virus test; Incidence; Individual; Infection; International; Intervention; Laboratories; Laboratory Study; Lateral; Liquid substance; Logistics; Measures; Methods; Monitor; Oral; Performance; Persons; Phase; Plasma; Population; Population Surveillance; Prevention trial; Privatization; Process; Product Approvals; Production; Public Health; Reproducibility; Research; Research Design; Research Infrastructure; Research Personnel; Resistance; Resources; Risk; Scientist; Serum; Sexual Partners; Small Business Innovation Research Grant; Specimen; Spottings; Stimulus; Surveillance Program; System; Taboo; Technology; Testing; Therapeutic; Triage; Validation; Viral Load result; Viral reservoir; Viremia; Whole Blood; assay development; base; clinical Diagnosis; clinical care; commercialization; cost; design; diagnostic assay; epidemiology study; field study; follow-up; health organization; high risk; improved; innovation; interest; intervention program; laboratory facility; point of care; pre-clinical; programs; public health relevance; research and development; scale up; screening; success; tool; transmission process; vaccine trial

 DESCRIPTION (provided by applicant): The objective of this Phase II project is to develop a commercially viable point of care Rapid HIV-1 Incidence Assay, the Asanté Rapid HIV-1 Recency Assay, and establish its suitability for determination of recency of HIV-1 infection in whole blood, plasma, serum specimens for epidemiological, research and surveillance purposes from liquid blood, serum or plasma for the estimation of HIV incidence rates. It is further intended to extend the application of the Assay to dried blood spot and oral fluid specimens. In addition, we intend to develop the Assay for a second intended use as a test to identify (either screening or confirmation) and determine recency of infection of specimens in individuals. For HIV incidence application, assays to estimate HIV incidence have been limited to complex laboratory based assays. However, many resource constrained areas need to be able to estimate HIV incidence rates in populations, yet do not have ready access to full laboratory facilities. The Assay, once established as suitable for population surveillance use, we believe, will also eventually be useful for providing for a second intended use: tailored therapeutic, counseling and contact follow-up of individuals at the point of care, coincident with diagnosis. Individual clinical use (with regulatory approval) will identify recently infected individuals and aggressively manage their treatment and followup. Intervention in early infections is important to begin treatment before virus reservoirs are established in the body rendering the HIV infection "incurable", reduce transmission rates by aggressively treating persons with such early infections which have the highest viral load and therefore the greatest risk of infection to sexual partners, and enable prioritization of contact tracing. The assay was developed in Phase I based on a combination of rapid lateral flow immunochromatography test technology proprietary to Sedia Biosciences and rapid incidence test technology developed and licensed from the U.S. Centers for Disease Control (CDC). The Assay will be scaled-up as a commercial product and validated and prepared for subsequent clinical trials during this phase. The project is of significant relevance to the CDC, as the CDC oversees a number of domestic and international programs to monitor the HIV epidemic in the U.S. and around the world. The proposed assay may be used as well by researchers, epidemiologists, other governmental and private public health organizations and vaccine trial program managers to understand and target the HIV epidemic, as well as assess the effectiveness of intervention programs and identify "hot spots" of infections. Sedia intends to collaborate with the CDC on this project by developing the assay according to CDC needs and specifications, but also by working with other stakeholders with a vested interest in the development of such assay such as WHO and CEPHIA (Consortium for the Evaluation and Performance of HIV Incidence Assays). CEPHIA provides a unique resource to independently evaluate HIV incidence assays and will add further credibility to the performance and utility of the assay.

 描述（申请人提供）：本II期项目的目的是开发一种商业上可行的床旁HIV-1快速发生率检测试剂盒（Asanté Rapid HIV-1 Recency Assay），并确定其适用于测定全血、血浆、血清标本中HIV-1感染的新近度，用于流行病学、研究和监测目的，血清或血浆用于估计HIV发病率。其进一步旨在将检测试剂盒的应用扩展至干血斑和口腔液样本。此外，我们计划开发该检测试剂盒的第二个预期用途，作为识别（筛查或确认）和确定个体标本感染的新近度的检测。对于HIV发病率应用，估计HIV发病率的测定仅限于基于复杂实验室的测定。然而，许多资源有限的地区需要能够估计人口中的艾滋病毒发病率，但没有现成的全面实验室设施。我们相信，一旦确定该检测试剂盒适用于人群监测，最终也将用于提供第二种预期用途：在诊断的同时，在护理点对个体进行定制治疗、咨询和接触随访。个体临床使用（经监管部门批准）将识别最近感染的个体，并积极管理其治疗和随访。对早期感染的干预对于在体内建立病毒储库之前开始治疗，从而使艾滋病毒感染“不可治愈”，通过积极治疗具有最高病毒载量并因此具有最大感染风险的早期感染者来降低传播率， 合作伙伴，并使接触者追踪的优先次序。该检测试剂盒在I期开发，基于Sedia Biosciences专有的快速侧向流免疫层析检测技术和美国疾病控制中心（CDC）开发和许可的快速发病率检测技术的组合。该检测试剂盒将作为商业产品进行放大，并在此阶段进行验证和准备，用于后续临床试验。该项目与疾病预防控制中心具有重要意义，因为疾病预防控制中心负责监督许多国内和国际项目，以监测美国和世界各地的艾滋病毒流行情况。研究人员、流行病学家、其他政府和私人公共卫生组织以及疫苗试验项目管理人员也可以使用拟议的检测方法来了解和瞄准HIV流行病，以及评估干预计划的有效性和识别感染的“热点”。Sedia打算与CDC合作，根据CDC的需求和规格开发检测试剂盒，同时与其他利益相关者合作开发此类检测试剂盒，如WHO和CEPHIA（HIV发病率检测试剂盒评估和性能联盟）。CEPHIA为独立评估HIV发病率检测提供了独特的资源，并将进一步提高检测性能和实用性的可信度。