OraQuick, a blood test for the speedy detection of hepatitis C virus (HCV) infection has been approved in US for sale.
OraQuick, developed by OraSure Technologies, Inc is considered the first rapid HCV test approved by the FDA for use in the United States.
OraQuick can detect hepatitis C antibodies in venous whole blood specimens.
“The OraQuick HCV test efficiently identifies previously undiagnosed HCV infected individuals who are at risk,” stated Eugene R. Schiff, MD, MACP, FRCP, MACG, AGAF, University of Miami School of Medicine.
Researchers at the University of Miami found OraQuick to be ser-friendly, practical and an important tool for rapid HCV antibody detection.
OraQuick HCV is the only rapid, point-of-care test for the detection of antibodies to the hepatitis C virus in venous whole blood specimens that is approved by US FDA, OraSure said in a press release.
The test, which utilizes the OraQuick technology platform, provides results in 20 minutes.
OraSure had previously received US FDA approval for its OraQuick ADVANCE Rapid HIV-1/2 Antibody Test for use with oral fluid, fingerstick and venous whole blood and plasma samples.
On a worldwide basis, there are an estimated 180 million people who are chronically infected with HCV, with an estimated 3 to 4 million individuals newly infected each year.
According to the World Health Organization, most cases of HCV infection are currently undiagnosed and up to 80 percent of HCV-positive individuals show no signs or symptoms.
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 Centers for Disease Control and Prevention (CDC), new infections in the U.S. are estimated at approximately 20,000 per year.
In December 2009, the Company received the CE mark for its OraQuick HCV Rapid Antibody Test for use with oral fluid, whole blood, serum and plasma specimens. The CE mark was required in order to sell the product in the European Union.
OraSure has entered into agreements with Merck & Co. (through its predecessor Schering Plough Corporation) to collaborate on the development and promotion of the OraQuick HCV test.
Under the terms of these agreements, the Company has been and 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 Company has obtained approval.
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices.
OraSure Technologies is the leading supplier of oral-fluid testing solutions for drugs of abuse and for the detection of antibodies to HIV.