Back grey_arrow_rt.gif
Rapid HCV Test from OraSure Technologies
  Excerpts regarding their rapid HCV test development from company conference call this morning.
Nov 24 2008
I would like to briefly discuss two very exciting and recent developments. The filing of our FDA pre-market approval application for a rapid Hepatitis C test and the transition of our hospital distribution arrangement with Abbott to a direct sales model, which we announced through a press release within the past hour.
As you know, we?ve been conducting clinical trials for use of an OraQuick HCV rapid antibody test on five specimen types; oral fluid, finger stick whole blood, venous whole blood, plasma and serum. Our clinical studies included data from over 3,000 participants and generated results consisted with the encouraging preclinical data that we previously announced publicly. We continue to believe that there is a substantial opportunity for a rapid HCV test.
On a worldwide basis, there are an estimated 180 million people who are chronically infected with HCV with an estimated 3 million to 4 million individuals newly infected each year. The prevalence of Hepatitis C infection is estimated to be four times that of HIV around the world. According to the World Health Organization, as many as 50% of persons infected with HCV are undiagnosed and up to 80% who have HCV show no signs or symptoms.
In the United States, there are an estimated 4 million Americans or 1.2% of the entire population that are or have been infected with Hepatitis C. Hep C is a curable disease. The existing treatment therapies can resolve in viral clearance ranging from as high as 50% to up to 80%, and new therapies are under development, which may improve these treatment rates.
We believe that the key to improving public health with respect to HCV is early diagnosis through expanded testing and screening initiatives. While we cannot predict if or when we will receive FDA approval, generally PMA submissions take 10 to 12 months before they are approved. The ultimate timing will depend on the extent of any FDA questions or requests for additional information and the result of an FDA inspection of our facilities, which is part of the process for PMA submissions in this complexity.
Additionally, we intend to file for CLIA waiver as soon as our PMA submission is approved. CLIA waive tests are simple laboratory tests and procedures that are cleared by the FDA for use outside of a laboratory. These tests are so simple and accurate as to render the likelihood of erroneous results negligible and pose no reasonable risk upon to the patient if the test is performed incorrectly.
Gaining a CLIA waiver for the HCV rapid test, as we have done for the HIV rapid antibody test, would thus substantially expand the available market for the product into include outreach settings, physicians? offices, and other non-laboratory organizations. We are now in the process of wrapping up some additional studies required to obtain a CLIA waiver. As I mentioned, we will file an application for a CLIA waiver as soon as we receive FDA approval for the HCV test.
We are also finishing up some additional clinical work needed to complete our submission for a CE Mark. This is required to sell the test in Europe, and we expect to make that filing in the next several months. The completion of the HCV clinical trials and the submission of our FDA application is a very significant milestone for the company. And I want to take this opportunity to thank and congratulate our R&D regulatory and operations groups who did an excellent job on this very important project.
  icon paper stack View Older Articles   Back to Top