OraSure Technologies has received FDA approval for OraQuick HCV antibody rapid blood test to find antibodies to the hepatitis C virus (HCV) for individuals 15 years and older.
According to OraSure Technologies, OraQuick is a test strip and does not require an instrument for diagnosis. It takes about 20 minutes to obtain results from the test and is not approved for HCV screening of the general population.
Jeffrey Shuren, director of the Center for Devices and Radiological Health at FDA, said: “Approval of OraQuick means that more patients can be notified of their HCV infection faster so that they can consult with their physicians for appropriate health measures. Getting faster treatment is an important public health step to control this dangerous disease.”
According to the US Centers for Disease Control and Prevention, there are approximately 3.2 million people in the US chronically infected with HCV and each year, about 17,000 people are newly infected.
Chronic HCV infection is a reason for liver transplants in the US and HCV is associated with an estimated 12,000 deaths annually. Approximately 75 to 85% of people who become infected with the hepatitis C virus develop chronic infection.