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FDA Approves First Rapid Hepatitis C Virus Antibody Blood Test

SUMMARY: The Food and Drug Administration (FDA) announced on June 25 that it has approved the first rapid test for hepatitis C virus (HCV), known as the OraQuick Hepatitis C Rapid Antibody Test. The test -- already available in Europe -- uses whole blood drawn from a vein, does not require laboratory processing, and returns results in about 20 minutes. A positive result should be followed up with a confirmatory test using traditional HCV testing methods, according to the FDA. OraSure Technologies expects to begin shipping the new test by early August. OraSure has also developed and is awaiting decisions on HCV tests that use a small amount of blood from a finger stick or oral fluid, as currently exist for HIV.

Below is an excerpt from a press release issued by OraSure describing the Hepatitis C Rapid Antibody Test and its approval.

OraSure Technologies Receives FDA Approval for
OraQuick HCV Rapid Test, the First Rapid HCV Test
Approved for Sale in the U.S.

Bethlehem, Pa. -- June 25, 2010 -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that its OraQuick Hepatitis C ("HCV") Rapid Antibody Test has been approved by the U.S. Food and Drug Administration ("FDA") for use in detecting HCV antibodies in venous whole blood specimens, making it the first rapid HCV test approved by the FDA for use in the United States.

"The OraQuick HCV test efficiently identifies previously undiagnosed HCV infected individuals who are at risk," said Eugene R. Schiff, MD, MACP, FRCP, MACG, AGAF, University of Miami School of Medicine. "We at the University of Miami found this test to be user-friendly, practical and an important tool for rapid HCV antibody detection."

"We believe that the OraQuick HCV Rapid Antibody Test, with its simplicity and speed, will be a critical tool in identifying more at risk individuals infected with hepatitis C in the U.S., and thus represents a significant market opportunity," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "Obtaining FDA approval of our OraQuick HCV Rapid Antibody Test for venous whole blood represents a major milestone for our Company."

OraQuick HCV is the only rapid, point-of-care test for the detection of antibodies to the hepatitis C virus in venous whole blood specimens that is approved by the FDA. The test, which utilizes the OraQuick technology platform, provides results in 20 minutes. The OraQuick HCV Rapid Antibody Test is the latest rapid test manufactured by OraSure to receive FDA approval. OraSure had previously received FDA approval for its OraQuick ADVANCE Rapid HIV-1/2 Antibody Test for use with oral fluid, fingerstick and venous whole blood and plasma samples.

In the U.S., there are an estimated 4.1 million Americans, or 1.6 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. On a worldwide basis, there are an estimated 180 million people who are chronically infected with HCV, with an estimated 3 to 4 million individuals newly infected each year.

According to the World Health Organization, most cases of HCV infection are currently undiagnosed and up to 80 percent of HCV-positive individuals show no signs or symptoms.

In December 2009, the Company received the CE mark for its OraQuick HCV Rapid Antibody Test for use with oral fluid, whole blood, serum and plasma specimens. The CE mark was required in order to sell the product in the European Union.

As previously announced, OraSure has entered into agreements with Merck & Co. (through its predecessor 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 Merck for a portion of its costs to develop the test and obtain regulatory approvals. Additionally, Merck will provide promotional support, including detailing the test in the physicians' office market in those countries in which the Company has obtained approval.

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 testing solutions for drugs of abuse and for the detection of antibodies to HIV.

For more information on the company, please go to www.orasure.com.

7/2/10

Sources

R Klein and K Struble (Food and Drug Administration). FDA Approves Rapid Test for Antibodies to Hepatitis C Virus. Press release. June 25, 2010.

OraSure Technologies. OraSure Technologies Receives FDA Approval for OraQuick(R) HCV Rapid Test, the First Rapid HCV Test Approved for Sale in the U.S. Press release. June 25, 2010.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


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