June 29, 2010
The U.S. Food and Drug Administration announced Friday it has approved the first rapid-result blood test for the hepatitis C virus. The test is manufactured by OraSure Technologies, which already has approval to sell it in Europe. FDA approved the OraQuick Hepatitis C Rapid Antibody Test for the testing of whole blood drawn from a vein of patients age 15 and older. Unlike existing HCV tests, the OraQuick test strip delivers results in 20 minutes and does not need to be processed by a laboratory. "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 FDA's Center for Devices and Radiological Health. "Getting faster treatment is an important public health step to control this dangerous disease." The new test should begin shipping to hospitals and other customers by late July or early August, said OraSure CEO Douglas Michels. The company continues to seek approval for similar HCV tests using finger-prick blood samples and oral fluid. To read FDA's announcement, visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217318.htm.
No comments have been made.
The content on this page is free of advertiser influence and was produced by our editorial team. See our content and advertising policies.
|HIV Vaccine Induces Sustained HIV Remission in Proof-of-Concept Study|
|Incidence of All Cancers but Lung Cancer Drops After HIV Group Stops Smoking|
|With Possibilities for Long-Acting HIV Treatment, Modern Science Creates Modern ART|
|New HIV Capsid Inhibitor Strongly Stops HIV Replication at Two Steps|
|What's Your Message to the Trump Administration About the Fight Against HIV?|
|PrEP Failure Case Underscores Importance of Regular HIV Testing|