OraSure Technologies Inc announces that it has submitted a pre-market approval (PMA) application to the US Food and Drug Administration (FDA) for a rapid test for antibodies to the Hepatitis C virus (HCV) utilizing OraSure Technologies’ OraQuick® technology platform. When approved, the OraQuick HCV test is expected to be the first rapid HCV test approved by the FDA for use in the United States.
The Company is seeking FDA approval for use of its 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.
The Company also intends to submit a request for CE mark approval of the OraQuick HCV within the next several months. CE mark approval is needed to sell the test in the European Union.
“The completion of our FDA submission for the OraQuick HCV test is the result of a tremendous effort by our regulatory, research and development and operations groups, and we are very grateful for all of their efforts,” said Douglas A Michels, President and CEO of OraSure Technologies. “We believe the market opportunity for a rapid HCV test, both here in the US and around the world, is very significant, and this submission represents the achievement of an important milestone towards commercialization. We look forward to launching this product in the US in collaboration with Schering-Plough Corporation once FDA approval is obtained.”
As previously announced, OraSure has entered into agreements with 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 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 United States and internationally.
