Cimit News
RADx® Tech Independent Test Assessment Program (ITAP) for Hepatitis B Virus
In collaboration with the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program is soliciting proposals to accelerate the validation, regulatory authorization, and commercialization of innovative point-of-care (POC) tests for hepatitis B virus surface antigen (HBsAg) detection.
More than half of individuals with hepatitis B are unaware of their infection status. Approximately 50%–70% of individuals with acute hepatitis B are asymptomatic, and those who progress to chronic hepatitis B are typically asymptomatic for several years to decades until the development of HBV-related complications including cirrhosis, hepatocellular carcinoma, or extra-hepatic manifestations. Without testing, individuals with HBV infection can unknowingly transmit the virus to others. Routine monitoring and treatment for chronic HBV infection can reduce morbidity and mortality, supporting the importance of early detection of HBV infection.
In collaboration with the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program is soliciting proposals to accelerate the validation, regulatory authorization, and commercialization of innovative point-of-care (POC) tests for hepatitis B virus surface antigen (HBsAg) detection.
More than half of individuals with hepatitis B are unaware of their infection status. Approximately 50%–70% of individuals with acute hepatitis B are asymptomatic, and those who progress to chronic hepatitis B are typically asymptomatic for several years to decades until the development of HBV-related complications including cirrhosis, hepatocellular carcinoma, or extra-hepatic manifestations. Without testing, individuals with HBV infection can unknowingly transmit the virus to others. Routine monitoring and treatment for chronic HBV infection can reduce morbidity and mortality, supporting the importance of early detection of HBV infection.