When approved, the OraQuick hepatitis C virus (HCV) test is expected to be the first rapid HCV test approved by the FDA for use in the US.
The company is seeking FDA approval for use of its OraQuick HCV test on five specimen types – oral fluid, fingerstick whole blood, venous whole blood, plasma and serum. The submission reflects the successful completion of clinical studies which include data from over 3,000 subjects, said OraSure.
The company also intends to submit a request for CE mark approval of the OraQuick HCV test within the next several months. As previously announced, OraSure has entered into agreements with Schering-Plough 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 Schering-Plough for a portion of its costs to develop the test and obtain regulatory approvals, and Schering-Plough will provide detailing and other promotional support for the test in the physicians’ office markets in the US and internationally.
Douglas Michels, president and CEO of OraSure, said: “The completion of our FDA submission for the OraQuick HCV test is the result of a tremendous effort by our regulatory, R&D and operations groups, and we are very grateful for all of their efforts. We look forward to launching this product in the US in collaboration with Schering-Plough once FDA approval is obtained.”