HCV Rapid Oral HCV Test-Orasure/Merck

From: nataphcvhiv@natap.org
Subject: NATAP: HCV Rapid Oral HCV Test-Orasure/Merck
Date: December 15, 2009 8:08:47 AM EST
To: hiv@natap.org, nataphcvhiv@natap.org, natapindustry@natap.org, natapdoctors@natap.org

NATAP http://natap.org/
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OraSure has entered into agreements with Merck & Co. (through its predecessor Schering Plough Corporation) to collaborate on the development and promotion of the OraQuick(R) 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 worldwide.

Dec 15, 2009 (M2 EQUITYBITES via COMTEX) -- -- Oral-fluid testing solutions provider OraSure Technologies Inc (Nasdaq:OSUR) declared on Tuesday the receipt of the CE mark for the company's OraQuick Rapid HCV Antibody Test to diagnose people with HCV infection.


A CE mark is required to sell this test in the 27 countries of the European Union.


The OraQuick Rapid HCV Antibody Test is the first and only rapid Hepatitis C test bearing a CE mark that can be used with oral fluid and the company plans to launch the test in Europe during the first quarter of 2010.


OraSure also said that it is actively seeking US Food and Drug Administration (FDA) approval of its OraQuick Rapid HCV Antibody Test.

OraSure Technologies Receives CE Mark for OraQuick(R) Rapid HCV Antibody Test
First and Only Oral Fluid Rapid HCV Test Bearing a CE Mark
OraQuick(R) Rapid HCV Antibody Test
The OraQuick(R) Rapid HCV Antibody Test by OraSure Technologies -- the first and only oral fluid rapid HCV test bearing a CE Mark.

BETHLEHEM, Pa., Dec. 15, 2009 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that it has received approval to affix the CE mark to its OraQuick(R) Rapid HCV Antibody Test. A CE mark is required to sell this test in the 27 countries that currently make up the European Union. The OraQuick(R) Rapid HCV Antibody Test is the first and only rapid Hepatitis C test bearing a CE mark that can be used with oral fluid.

The European Union requires companies to comply with the Medical Devices Directive ("MDD") and In Vitro Diagnostics Directive ("IVDD") in order to sell medical devices in Europe. The CE mark is evidence that OraSure and its OraQuick(R) Rapid HCV Antibody Test meet the quality and other requirements of these directives. The Company is currently pursuing the required individual country registrations and expects to begin selling the test in Europe during the first quarter of 2010.

"We believe that the OraQuick(R) Rapid HCV Antibody Test, with its ability to test using a simple oral fluid or finger-stick blood sample, will be a valuable tool in identifying more individuals infected with Hepatitis C," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "CE mark approval of our OraQuick(R) Rapid HCV Antibody Test represents a significant achievement and major milestone for our Company."

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. According to the World Health Organization, most HCV infection is currently undiagnosed and up to 80 percent who have HCV show no signs or symptoms.

According to a new report issued by the UK Health Protection Agency on December 11, 2009, entitled "Hepatitis C in the UK -- The Health Protection Agency Annual Report 2009," it is currently estimated that approximately 185,000 individuals in the UK are chronically infected with Hepatitis C, including more than 8,000 people who were diagnosed in 2008 in England.

"This new hepatitis C test will help to diagnose people before their livers are damaged beyond repair," said Charles Gore, Chief Executive of The Hepatitis C Trust, the national charity for HCV in the United Kingdom. "Hepatitis C is preventable and treatable so it's a scandal that the death toll continues to rise simply because people haven't yet been diagnosed. The UK desperately needs to diagnose the 100,000 patients who are unaware they are living with the virus and to stop further transmissions. This simple, quick test will allow us to reach more people who would otherwise not have access to testing."

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(R) 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 worldwide.

With the CE mark, the OraQuick(R) Rapid HCV Antibody Test is the second rapid test manufactured by OraSure to receive such approval. In June 2007, OraSure received approval to affix the CE mark to its OraQuick ADVANCE(R) Rapid HIV-1/2 Antibody Test which is currently being sold widely in the European Union. OraSure is also actively seeking approval of its OraQuick(R) Rapid HCV Antibody Test by the U.S. Food and Drug Administration (FDA).

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.

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