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FDA Approves HCV Rapid Antibody Test for Fingerstick Blood Samples

SUMMARY: OraSure Technologies, Inc. announced this week that the U.S. Food and Drug Administration (FDA) has approved the OraQuick HCV Rapid Antibody Test for detecting hepatitis C virus (HCV) in blood from a simple fingerstick. This new indication for the test -- which was previously approved for testing blood drawn from a vein -- will simplify HCV screening, especially in non-clinical settings.

Below is an edited excerpt from an OraSure Technologies press release describing the test and its use.

OraSure Technologies Receives FDA Approval for Its OraQuick(R) HCV Rapid Test Using Fingerstick Whole Blood

Bethlehem, Pa. -- February 22, 2011 -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that its OraQuick HCV Rapid Antibody Test has now been approved by the U.S. Food and Drug Administration ("FDA") for use in detecting HCV antibodies with a fingerstick whole blood sample. The fingerstick whole blood claim is the second application to be approved by the FDA for the OraQuick(R) HCV test. The product received an initial approval for use in persons at risk for HCV infection with venous whole blood specimens in June 2010.

The OraQuick HCV Rapid Antibody Test is the only rapid, point-of-care test for the detection of antibodies to the hepatitis C virus that is approved by the FDA. The test, which utilizes the OraQuick technology platform, provides results in 20 minutes.

"Receiving FDA approval to test individuals at risk using a fingerstick whole blood sample significantly expands the flexibility and versatility of our OraQuick Rapid HCV Antibody Test," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "By eliminating the need for a blood draw, healthcare providers will be able to identify more individuals infected with hepatitis C and get them into care."

There are an estimated 4.1 million Americans, or 1.6 percent of the U.S. population, that are or have been infected with HCV. 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.

The company previously received approval to affix the CE mark to its OraQuick HCV test in December 2009 for use with oral fluid, fingerstick whole blood, venous whole blood, serum and plasma. 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. (NYSE:MRK), through its predecessor Schering Plough Corp., to collaborate on the development and promotion of the OraQuick HCV test. Under these agreements, Merck will provide detailing and other promotional support for the test in the physicians' office markets in the United States and internationally.

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.

2/25/11

Source
OraSure Technologies. OraSure Technologies Receives FDA Approval for Its OraQuick(R) HCV Rapid Test Using Fingerstick Whole Blood. Press release. February 22, 2011.



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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