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

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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.