Rapid Point-of-Care Assay for detecting High Risk Human Papillomavirus

用于检测高风险人乳头瘤病毒的快速护理点检测

• 批准号: 7296341
• 负责人: DAVID Lee DOLINGER
• 金额: $ 10万
• 依托单位: IQUUM, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-30 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7296341
• 关键词: Accounting; Americas; Biological Assay; Cancer Death Rates; Cancer Etiology; Capital; Caring; Cell Line; Cells; Cervical; Cervical Cancer Screening; Clinic; Clinical; Clinical Research; Clinics and Hospitals; Collaborations; Colposcopy; DNA; Data; Detection; Developed Countries; Developing Countries; Development; Devices; Diagnostic; Disadvantaged; Disease; Dose; Ensure; Europe; Excision; Exhibits; Figs - dietary; Funding; Future; Genotype; Goals; HPV-High Risk; Health; Hospital Information Systems; Hospitals; Hour; Human; Human Cloning; Human Papillomavirus; Human Resources; Human papillomavirus 16; Human papillomavirus 18; Hybrids; Incidence; Individual; Infection; Intellectual Property; Intervention; Laboratories; Letters; Licensing; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Manuals; Marketing; Medical Surveillance; Medically Underserved Area; Methods; Minority; Modality; Modeling; Molecular; New York; Nucleic Acid Amplification Tests; Nucleic Acids; Numbers; Operative Surgical Procedures; Papillomavirus; Patients; Penetration; Persons; Phase; Physicians' Offices; Polymerase Chain Reaction; Populations at Risk; Preparation; Process; Public Health; Range; Rate; Reagent; Reporting; Research; Resources; Risk; Rural Health Centers; Sampling; Scanning; Signal Transduction; Standards of Weights and Measures; Step Tests; Swab; System; Technology; Temperature; Testing; Time; Training; Tube; United States Food and Drug Administration; University Hospitals; Vaccines; Viral; Visit; Whole Blood; Woman; base; cancer therapy; commercialization; concept; cost; cross reactivity; disability; disorder prevention; follow-up; improved; inhibitor/antagonist; internal control; melting; mortality; novel; point of care; preclinical study; touchscreen

DESCRIPTION (provided by applicant): We propose to develop a highly sensitive and rapid point-of-care nucleic acid test based on IQuum's lab-in-a-tube (Liat(tm)) platform for the detection and genotyping of high risk Human Papillomavirus (HPV) from cervical swab samples. The Liat HPV Assay will utilize the Liat Analyzer to enable the minimally trained personnel to perform the HPV test at a hospital, clinic or physician's office in 1 hour. By enabling effective and sensitive single visit HPV testing, we expect that the Liat assay will allow clinicians to identify more women at risk for cervical cancer and provide immediate and effective intervention, thereby significantly lowering the incidence of cervical cancer. The Liat HPV Assay overcomes the limitations of current HPV tests, whose long turnaround time and technical complexity requires testing to be performed in centralized laboratories, resulting in missed opportunities for disease prevention due to significant patient loss to follow-up and lack of penetration into resource-poor regions in the US and abroad. In Phase I of this Fast Track project, we intend to prove the feasibility of developing a 1 hour sample-to- result Liat HPV Assay by developing melting-point PCR assays for HPV-16 and HPV-18 and Liat-based extraction for HPV nucleic acids from HPV-containing cervical cell lines. In Phase II, we propose to expand the assay developed in Phase I to include the majority of high risk HPV types that are found in cervical cancer, develop Liat sample preparation for cervical samples, as well as integrate all assay components, including internal controls, into a single Liat tube for multiplex HPV detection. We further intend to characterize and validate the Liat HPV Assay in a pre-clinical study. At the conclusion of this Fast Track project, we will be prepared to submit the Liat HPV assay for FDA- approved clinical study. The assay will be among the first point-of-care nucleic acid tests, and will provide significant benefit to public health.

描述（由申请人提供）：我们建议基于 IQuum 的管内实验室 (Liat(tm)) 平台开发一种高灵敏度、快速的护理点核酸检测，用于从宫颈拭子样本中检测高风险人乳头瘤病毒 (HPV) 并进行基因分型。 Liat HPV 检测将利用 Liat 分析仪，使经过最低限度培训的人员能够在 1 小时内在医院、诊所或医生办公室进行 HPV 检测。通过实现有效且灵敏的单次 HPV 检测，我们预计 Liat 检测将使临床医生能够识别更多有宫颈癌风险的女性，并提供立即有效的干预措施，从而显着降低宫颈癌的发病率。 Liat HPV 检测克服了当前 HPV 检测的局限性，其周转时间长且技术复杂，需要在集中实验室进行检测，导致患者大量失访，且缺乏对美国和国外资源匮乏地区的渗透，从而导致错失疾病预防的机会。在该快速通道项目的第一阶段，我们打算通过开发 HPV-16 和 HPV-18 的熔点 PCR 检测以及基于 Liat 的方法从含有 HPV 的宫颈细胞系中提取 HPV 核酸，证明开发 1 小时样品到结果 Liat HPV 检测的可行性。在第二阶段，我们建议扩大第一阶段开发的检测方法，以包括宫颈癌中发现的大多数高风险HPV类型，开发用于宫颈样本的Liat样品制备，以及将所有检测组件（包括内部对照）整合到单个Liat管中以进行多重HPV检测。我们进一步打算在临床前研究中表征和验证 Liat HPV 检测。在此快速通道项目结束时，我们将准备提交 Liat HPV 检测用于 FDA 批准的临床研究。该检测将是首批即时核酸检测之一，将为公众健康带来重大益处。