OraSure Receives HCV Test Approval - Analyst Blog

OraSure Technologies (OSUR) recently announced that the Food and Drug Administration (FDA) approved its OraQuick Hepatitis C (HCV) Rapid Antibody Test, which is utilized for identifying HCV antibodies in venous whole blood specimens. OraQuick HCV test is the first rapid HCV test to receive approval. Earlier, OraSure received CE Mark approval of this test in December 2009 for use with whole blood, serum and plasma samples.

OraSure’s OraQuick HCV test is expected to identify, in a simple and speedy manner, undiagnosed HCV persons considered to be at risk. This test is, till date, the sole approved point-of-care (POC) test for the identification of antibodies to the hepatitis C virus in venous whole blood samples.

OraSure’s OraQuick HCV test uses the OraQuick technology platform and provides readings in about 20 minutes. Prior to receiving approval for this test, OraSure had obtained FDA approval for its OraQuick ADVANCE Rapid HIV-1/2 Antibody Test for use with venous whole blood and plasma samples.

OraSure has an agreement with Merck & Co. (MRK), via Schering Plough Corporation, to collaborate on the development and marketing of the OraQuick HCV test. Under the deal terms, OraSure will continue to be reimbursed by Merck for a portion of the expenses incurred to develop and obtain regulatory approval for the test.

Merck will also provide promotional assistance, including explanation of the test in the physicians’ office setup, in select countries in which OraSure has obtained regulatory clearance.

It is estimated that about 4.1 million Americans, or approximately 1.6% of the population, are infected with HCV. The Centers for Disease Control and Prevention noted that about 20,000 fresh cases of infection are reported in the US each year.

On a global basis, it is estimated that about 180 million individuals are infected with HCV on a chronic basis, with about 3 to 4 million fresh cases each year. The World Health Organization has stated that a majority of the cases with HCV infection go undiagnosed and as many as 80% of HCV-positive cases do not exhibit any symptom.

OraSure manufactures and sells oral fluid specimen collection devices based on its proprietary oral fluid technologies, diagnostic products including immunoassays and in vitro diagnostic tests, and certain other medical devices. OraSure is also a leading supplier of oral-fluid solutions for testing drugs of abuse as well as identification of antibodies to HIV (human immunodeficiency virus).