FDA approves OraSure Technologies’ hepatitis C test

SILVER SPRING, Md. The Food and Drug Administration has approved a new rapid blood test for detecting hepatitis C, the agency said Friday.

The FDA approved Bethlehem, Pa.-based OraSure Technologies’ OraQuick HCV rapid antibody test, a test strip that delivers results in about 20 minutes. The test however, is not approved for HCV screening of the general population.

About 3.2 million people in the United States are chronically infected with HCV, and 17,000 people are newly infected each year. The disease can lead to liver disease and cancer, and is associated with around 12,000 deaths in the United States annually.

“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,” FDA Center for Devices and Radiological Health director Jeffrey Shuren stated. “Getting faster treatment is an important public health step to control this dangerous disease.”

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