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: 9138913
• 负责人: Ronald William Mink
• 金额: $ 100万
• 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 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9138913
• 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; Epidemiology; Evaluation; Funding; Gold; HIV; HIV Infections; HIV-1; Hot Spot; Human immunodeficiency virus test; Incidence; Individual; Infection; International; Intervention; Laboratories; Laboratory Study; Lateral; Licensing; Liquid substance; Logistics; Marketing; Measures; Methods; Monitor; Oral; Performance; Persons; Phase; Plague; Plasma; Population; Population Surveillance; Prevention trial; Process; Product Approvals; Production; Public Health; 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; Work; assay development; base; clinical Diagnosis; clinical care; commercialization; cost; design; diagnostic assay; field study; follow-up; health organization; high risk; improved; innovation; interest; intervention program; laboratory facility; meetings; 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(由申请人提供)：该第二阶段项目的目标是开发一种商业上可行的艾滋病毒-1感染快速检测方法，即快速艾滋病毒-1新近性检测方法，并确定其适用于确定全血、血浆、用于流行病学、研究和监测目的的全血、血浆、血清或血浆中艾滋病毒-1感染的新近性，以估计艾滋病毒发病率。此外，还打算将该分析的应用范围扩大到干血斑和口腔液体标本。此外，我们打算开发该检测方法，用于第二次预期用途，作为识别(筛查或确认)和确定个体样本感染的近期情况的测试。对于艾滋病毒发病率的应用，估计艾滋病毒发病率的分析一直局限于复杂的基于实验室的分析。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，但还不能随时获得完整的实验室设施。我们相信，一旦被确定为适合于人口监测用途，该检测最终也将有助于提供第二种预期用途：在与诊断相一致的情况下，在护理点对个人进行量身定制的治疗、咨询和接触随访。个人临床使用(经监管部门批准)将识别最近感染的个人，并积极管理他们的治疗和随访。对早期感染的干预是重要的，在体内建立病毒储存库使艾滋病毒感染“无法治愈”之前开始治疗，通过积极治疗病毒载量最高的这种早期感染患者来降低传播率，因此对性行为的感染风险最大。 合作伙伴，并实现联系人跟踪的优先顺序。该检测是在第一阶段开发的，结合了赛迪亚生物科学公司拥有专利的快速横向流动免疫层析测试技术和从美国疾病控制中心(CDC)开发并获得许可的快速发病率测试技术。该分析将作为商业产品扩大规模，并为这一阶段的后续临床试验进行验证和准备。该项目与美国疾病控制与预防中心密切相关，因为疾病控制与预防中心负责监督多个国内和国际项目，以监测美国和世界各地的艾滋病疫情。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经理也可以使用拟议的分析方法来了解和瞄准艾滋病毒流行，以及评估干预计划的有效性和确定感染的“热点”。SEDIA打算在这个项目上与疾控中心合作，根据疾控中心的需求和规范开发检测方法，但也通过与世卫组织和CEPHIA(艾滋病毒发病率检测评估和性能联盟)等在开发这种检测方法方面有既得利益的其他利益攸关方合作。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的可信度和实用性。