Rapid, Point-of-Care Nucleic Acid Test for HCV

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Rapid, Point-of-Care Nucleic Acid Test for HCV CrossLife Technologies Inc. Project Summary/Abstract Approximately 500 000 people die each year from hepatitis C-related liver diseases [1]. The hepatitis C virus can cause both acute and chronic hepatitis infection [1-2]. Over time, chronic Hepatitis C can cause serious health problems including liver damage, liver failure, and even liver cancer. Early detection can save lives. If the antibody test is reactive, an additional nucleic acids based (RNA) test is needed to determine if a person is currently infected with Hepatitis C. If the RNA test is positive, this means a person currently has Hepatitis C and should talk to a doctor and treating the disease. There is an urgent need for sensitive and specific point-of-care (POC) diagnostics for HCV. Nucleic-acid based POC tests have the potential to offer timely, sensitive and accurate diagnosis of HCV for imparting proper care and treatment – especially in settings without robust clinical laboratory support. The availability of a POC assay to distinguish which HCV seropositive patients are infected and ascertain whether patients have developed a sustained virologic response (SVR) will make it possible to treat patients on a global basis in the current era of highly effective pan-genotypic HCV regimens. Therefore, we aim to develop a rapid, multiplex test that detects and genotypes all six genotypes of HCV 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 qRT-PCR data on the same samples. We will also 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.