Singapore, June 28, 2010: The US Food and Drug Administration has approved the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals over 15 years of age.

The OraQuick HCV Rapid Antibody Test, manufactured by Bethlehem, Pennsylvania-based OraSure Technologies, is used to test individuals who are prone to HCV infection and people with signs or symptoms of hepatitis. OraQuick is a test strip and does not require an instrument for diagnosis. It takes about 20 minutes to obtain results from the test. It is not approved for HCV screening of the general population.

HCV is transmitted through exposure to infected blood, which, for example, can occur during intravenous drug use. The virus can also be transferred from an infected mother to her child. Hepatitis C can lead to liver inflammation and dysfunction and, over time, to liver disease and liver cancer.

"Approval of OraQuick means that more patients can be notified of their HCV infection faster so that they can consult their physicians for appropriate health measures. Getting faster treatment is an important public health step to control this dangerous disease," said Dr Jeffrey Shuren, Director of the FDA's Center for Devices and Radiological Health.

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 leading reason for liver transplants in the US and HCV is associated with an estimated 12,000 deaths annually. Approximately 75-85 percent of people who become infected with the hepatitis C virus develop chronic infection.