OraSure Technologies (OraSure) has reported the recent filing of a pre-market approval (PMA) amendment with the FDA for the OraQuick Rapid HCV Antibody Test. The amendment contains additional clinical data requested by the FDA for use of the test in detecting antibodies to the hepatitis C Virus (HCV) in venous whole blood samples.
When approved for use with venous whole blood, the OraQuick HCV test is expected to be the first rapid HCV test approved by the FDA for use in the US. The company is also currently completing an additional clinical study to obtain FDA approval of the OraQuick HCV test for use with oral fluid and fingerstick whole blood.
Filing of the amendment with the FDA follows the received approval to affix the CE mark to its OraQuick HCV Test for use with oral fluid, fingerstick blood, venous whole blood, serum and plasma.
The CE mark is required to sell this test in the 27 countries that currently make up the European Union. The OraQuick Rapid HCV Antibody Test is the only rapid Hepatitis C test bearing a CE mark that can be used with oral fluid.
OraSure has entered into agreements with Merck & Co, through its predecessor Schering Plough to collaborate on the development and promotion of the OraQuick HCV test, as reported previously. Under these agreements, Merck will provide detailing and other promotional support for the test in the physicians’ office markets in the US and internationally.