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.
The Company also intends to submit a request for CE mark approval of the OraQuick® HCV test 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 U.S. 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 U.S. in collaboration with Schering-Plough Corporation once FDA approval is obtained."
On a world-wide basis, there are an estimated 180 million people who are chronically infected with HCV, with an estimated three to four 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 fifty percent of persons infected with HCV are undiagnosed and up to eighty percent who have HCV show no signs or symptoms. In the U.S., there are an estimated four million Americans, or 1.3 percent of the population, that are or have been infected with HCV. According to the Centers for Disease Control and Prevention ("CDC"), new infections in the U.S. are estimated at approximately 20,000 per year.
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.
About Hepatitis C
Hepatitis C is the major cause of acute Hepatitis and chronic liver disease and, if left undiagnosed and treated, can lead to cirrhosis of the liver, liver cancer, liver failure and death. According to the CDC it is estimated that seventy-five to eighty-five percent of those people who become infected with the hepatitis C virus develop chronic infection, and five to twenty percent eventually develop cirrhosis of the liver.
Although HCV is a significant health issue, it is a curable disease. With current treatment therapies, the rates of sustained viral clearance are as high as fifty percent in cases of infection by Genotype 1, the most common form of HCV, and as high as eighty percent with the less commonly occurring Genotypes 2 and 3 of the virus. New therapies are under development which may improve these treatment rates. OraSure believes the key to improving public health with respect to this disease is early diagnosis through wide-spread testing.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities.
OraSure Technologies is the leading supplier of oral-fluid collection devices and assays to the public health and life insurance markets for the detection of antibodies to HIV. In addition, the Company supplies oral-fluid testing solutions for drugs of abuse testing. For more information on the Company, please go to orasure.
OraSure Technologies
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