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.
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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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This press release contains certain forward-looking statements, including with respect to product sales and registrations. Actual results could be significantly different. Factors that could affect results include the ability to market and sell products, whether through an internal, direct sales force or third parties; ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements; changes in relationships, including disputes or disagreements, with strategic partners and reliance on strategic partners for the performance of critical activities under collaborative arrangements; failure of distributors or other customers to meet purchase forecasts or minimum purchase requirements for the Company's products; impact of replacing distributors and success of direct sales efforts; inventory levels at distributors and other customers; impact of competitors, competing products and technology changes; impact of the economic downturn, high unemployment and credit crisis; ability to develop, commercialize and market new products; market acceptance of oral fluid testing or other products; changes in market acceptance of products based on product performance and extended shelf life; continued bulk purchases by customers, including governmental agencies, and the ability to fully deploy those purchases in a timely manner; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical product components; availability of related products produced by third parties or products required for use of our products; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; history of losses and ability to achieve sustained profitability and ability to utilize net operating loss carryforwards or other deferred tax assets; volatility of the Company's stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including changes in international funding sources; loss or impairment of sources of capital; ability to meet financial covenants in agreements with financial institutions; ability to retain qualified personnel; exposure to patent infringement, product liability, and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; ability to identify, complete and realize the full benefits of potential acquisitions; and general political, business and economic conditions. These and other factors are discussed more fully in the Securities and Exchange Commission ("SEC") filings of OraSure Technologies, including its registration statements, its Annual Report on Form 10-K for the year ended December 31, 2008, its Quarterly Reports on Form 10-Q, and its other filings with the SEC. Although forward-looking statements help to provide complete information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.
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CONTACT: OraSure Technologies, Inc.
Ronald H. Spair, Chief Financial Officer
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