Infection rates of hepatitis C virus (HCV) in the United States of America (USA) have steadily risen since 2010. There are approximately 2 million people infected with HCV in the USA with up to 140,000 new infections occurring annually. Globally, there are an estimated 71 million people living with HCV and it is estimated that as many as 50% may be unaware of their infection.
The World Health Organization’s (WHO) goals for eliminating HCV infection by 2030 will require better case identification/diagnosis and linkage to care. A point-of-care diagnostic that is accurate, simple, rapid, and affordable will greatly increase the diagnoses of HCV infections and link those infected to care. The current process to diagnose an active infection with HCV requires at least two tests and can take up to one week for results. An initial point-of-care screen for HCV antibodies in blood is followed, if positive, by a viral load test performed in a centralized laboratory. Either the same sample is reflex tested, or the patient must supply an additional sample. One-step testing for active HCV infections utilizing a point-of-care assay would allow patients to receive their result in a single visit and allow for rapid care planning and management.
The purpose of this Notice of Special Interest is to announce that the National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the National Cancer Institute (NCI) are encouraging applications in the area of translational research and development of rapid Point-of-Care diagnostics that will diagnose active viremic HCV infections. Applicants are encouraged to consult the target product profile for HCV diagnostics published by Reipold et al., BMC Infectious Diseases 2017, 17(Suppl 1):707 (https://doi.org/10.1186/s12879-017-2770-5) for additional preferred assay qualities and characteristics. In addition, the NCI has special interest in developing Point-of-Care testing for HCV diagnosis that will lead to further assessment of the liver damage, stage of fibrosis/cirrhosis and ultimately the risk for liver cancer.