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

描述（由申请人提供）：我们建议基于IQuum的lab-in-a-tube （Liat(tm)）平台开发一种高灵敏度和快速的即时护理核酸检测方法，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，使最低限度的培训人员在医院，诊所或医生办公室在1小时内进行HPV检测。通过有效和敏感的单次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妇女，并提供即时和有效的干预，从而显著降低宫颈癌的发病率。Liat HPV检测克服了目前HPV检测的局限性，这些检测的周转时间长，技术复杂，需要在集中的实验室进行检测，由于大量患者因随访而丢失，以及在美国和国外资源贫乏地区缺乏渗透，导致错过了疾病预防的机会。在这个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检测以及从含有HPV的宫颈细胞系中提取HPV核酸来证明开发1小时样品到结果的Liat HPV检测的可行性。在第二阶段，我们建议扩展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（包括内部控制）整合到单个Liat管中进行多重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。在这个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，并将为公共卫生带来重大益处。

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.