FDA Approves Rapid Test for Antibodies to Hepatitis C Virus

FDA NEWS RELEASE

For Immediate Release: June 25, 2010
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

The U.S. Food and Drug Administration today announced approval of the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals 15 years and older.

The OraQuick HCV Rapid Antibody Test is used to test individuals who are at risk for infection with HCV and people with signs or symptoms of hepatitis. 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.

OraQuick is a test strip and does not require an instrument for diagnosis. It takes about 20 minutes to obtain results from the test.

“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,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Getting faster treatment is an important public health step to control this dangerous disease.”

OraQuick is not approved for HCV screening of the general population.

According to the U.S. Centers for Disease Control and Prevention, there are approximately 3.2 million people in the United States chronically infected with HCV and each year, about 17,000 people are newly infected. Chronic HCV infection is a leading reason for a liver transplants in the United States and HCV is associated with an estimated 12,000 deaths annually. Approximately 75 to 85 percent of people who become infected with the hepatitis C virus develop chronic infection.

OraQuick is manufactured by Bethlehem, Penn.-based OraSure Technologies Inc.

For more information:

FDA: Medical Devices
NIH: Hepatitis C
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217318.htm