Bethlehem, PA-based OraSure Technologies (NASDAQ:OSUR) has received the FDA's OK for its OraQuick hepatitis C rapid antibody test. It is the the first rapid HCV test approved by the FDA for use in the U.S., according to a company statement.
The test, which utilizes the OraQuick technology platform, provides results in 20 minutes. "The OraQuick HCV test efficiently identifies previously undiagnosed HCV infected individuals who are at risk," explains Eugene Schiff, University of Miami School of Medicine. "We at the University of Miami found this test to be user-friendly, practical and an important tool for rapid HCV antibody detection."
The test is for use on whole blood samples. OraSure is also seeking regulatory approval for similar tests that use finger-prick blood samples and oral fluids, and hopes to get those by early 2011, according to The Morning Call.
In the U.S., there are an estimated 4.1 million Americans, or 1.6 percent of the population, that are or have been infected with HCV. According to the CDC, new infections in the U.S. are estimated at approximately 20,000 per year. On a worldwide basis, there are an estimated 180 million people who are chronically infected with HCV, with an estimated 3 million to 4 million individuals newly infected each year.
OraSure has entered into agreements with Merck--through Schering Plough--to collaborate on the development and promotion of the OraQuickHCV test. Under the terms of these agreements, the company will be reimbursed by Merck for a portion of its costs to develop the test and obtain regulatory approvals. Additionally, Merck will provide promotional support, including detailing the test in the physicians' office market in those countries in which the test has been approved, according to an OraSure statement.
- see the OraSure statement
- get the report from The Morning Call