Device for point-of-care nucleic acid purification and detection of HCV

Phase I SBIR proposals will be accepted. Fast-track proposals will not be accepted. Phase I clinical trials will not be accepted. Number of anticipated awards: 1 Budget (total costs): Phase I up to $243,500 for up to 6 months; Phase II of up to $1,972,828 and a Phase II duration of up to 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Background Hepatitis C virus (HCV) infection is a major global health problem and chronic HCV infection is a leading cause of cirrhosis and liver cancer. HCV infects an estimated 2.4 million people in the U.S. and 58 million people, globally. Effective and well-tolerated direct acting antiviral (DAA) drugs are available for the treatment of HCV infections and the World Health Organization (WHO) has established elimination goals of 90% reductions in the number of new HCV cases and 65% reductions in deaths associated with HCV infection by the year 2030. Achievement of these goals will require expanding access to HCV testing as only 20% of current infections have been globally diagnosed. Current HCV infections are diagnosed by the detection of either circulating HCV RNA or HCV core antigen in a person's blood. HCV diagnostic testing methods often have high costs, slow turnaround times, and need to be performed in a laboratory, which lead to access problems and the potential to lose patients to health care provider follow up after a positive diagnosis. Ideally, HCV diagnosis would occur at the point of care while the patient waits, allowing for immediate linkage to care and treatment in people with HCV infections. Currently there are no point-of-care tests for the detection of HCV RNA available in the US. The development of a simple and inexpensive device that can perform nucleic acid extraction and detection workflows with minimal user intervention would allow for the diagnosis of HCV infection at the point of care, and greatly expand access to HCV diagnostic testing.