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Bethlehem-based OraSure gets FDA approval for hepatitis C test
  Published: Tuesday, February 22, 2011, 10:33 AM
OraSure Technologies in Bethlehem has received U.S. Food and Drug Administration approval for a rapid hepatitis C test, the company announced today.
The approval for the new OraQuick HCV Rapid Antibody finger-stick test follows about eight months after the FDA approved a similar blood-draw test for the blood-borne pathogen.
The difference between the tests is how the sample is obtained, said Ron Ticho, OraSure's vice president of communications.
"This particular procedure now does not require ... a blood draw. Instead it can be done with a simple prick of the finger and a smaller sample of blood," similar to a diabetes blood test, Ticho said.
The approval makes the test more "versatile," he said, and "will help health care professionals to identify more individuals with this disease."
Hepatitis C affects an estimated 4.1 million Americans and 180 million people worldwide. The virus can cause cirrhosis, liver failure and liver cancer.
The test was recognized by Popular Science magazine as one of the top 100 technology innovations of 2010.
The company has plans to make it even less invasive, eventually looking to obtain approval for an oral fluid version of the test, similar to the process used to develop its HIV tests, Ticho said.
OraSure Technologies Receives FDA Approval for Its OraQuick(R) HCV Rapid Test Using Fingerstick Whole Blood
Written by TradersHuddle Staff
Tuesday, 22 February 2011 06:07
BETHLEHEM, Pa., Feb. 22, 2011 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. 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® 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
The OraSure Technologies, Inc. logo is available at
CONTACT: Investor Contact:
Ronald H. Spair
Chief Financial Officer
Media Contact:
Jennifer Moritz
Zer0 to 5ive for OraSure Technologies
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