Point of Care HPV 16/18/45 DNA Test for Cervical Cancer

宫颈癌的HPV 16/18/45 DNA检测。

Point of Care HPV 16/18/45 DNA Test for Cervical Cancer. CrossLife Technologies Inc. Project Summary/Abstract Human cervical cancer is the fourth most common cancer among women worldwide [1]. Despite cervical cancer has been thoroughly studied and the mortality has been significantly reduced through efficient screening, these preventive programs are found to be less effective in developing countries [2-3]. There are unmet needs for nucleic acids new diagnostics that can be applied at the point-of-care to detect HPV 16/18/45 DNA for cervical cancer. A simple, sensitive, multiplex and robust testing kits for detecting cervical cancer biomarker HPV 16/18/45 DNA at the point-of-care will be developed. The competitive advantage of TARA is the utilization of a novel chemical reaction with similar detection sensitivity and specificity compared to the Hologic Aptima HPV 16 18/45 Genotype assay and simple readout on paper-strip more suitable for field devices without an instrument. TARA also offers the potential for direct detection in complex sample matrices, such as cervical sample or blood, without sample preparation. Building on the chemistry and device innovations (TARAplex, and 1D paper network), we have made significant progress and begun to explore integration through our established collaborations. We aim to develop a rapid point-of-test that detects HPV at the point-of-need in < 30 minutes and is appropriate for non-laboratory settings and non-technical personnel. Our proprietary test exploits a novel probe reaction chemistry that allows multiplexed detection of DNA or RNA without sample purification, making it operable as a simple, hand-held test. Patient samples to be input directly into the device without pre-processing and a disposable cartridge carry out amplification of all targets and reports visible results that can be read by eye. We expect a sensitivity (>90%) and specificity (>90%) to the U.S. commercially-available the Aptima HPV 16 18/45 Genotype assay (HOLOGIC) data on the same samples. We will conduct a large-scale validation and obtain World Health Organization (WHO) expedited review approval and recommendation for procurement on our product and market it first to non-governmental organizations (NGO) such as the Doctors Without Borders or the Gates Foundation. We will obtain USFDA 510 K clearance in Phase 3 in order to market our product in the U.S.