BETHLEHEM, Pa., Nov. 22, 2010 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR), the market leader in oral fluid diagnostics, today announced that the U.S. Food and Drug Administration ("FDA") has granted an investigational device exemption (IDE) for the Company to conduct the final phase of clinical testing for FDA approval of its OraQuick® Rapid HIV-1/2 Antibody Test for sale in the consumer or over-the-counter ("OTC") market.
Receipt of the IDE allows the Company to proceed with the final phase of clinical testing which consists of a study in which individuals will conduct unsupervised self-testing using the investigational OTC version of the OraQuick® HIV test with an oral fluid collection.
As previously announced, OraSure has already initiated site selection, training and preparation and Institutional Review Board (IRB) review for this final phase and expects enrollment to begin before the end of the year.
"We are extremely pleased to have approval to begin the final phase of studies to support our efforts to obtain FDA approval for an over-the-counter offering of our OraQuick® HIV test," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "We look forward to continuing our work with the FDA and other members of the community to make a home use rapid HIV test available in the United States."
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. For more information on the Company, please go to .
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This press release contains certain forward-looking statements, including with respect to expected clinical studies and regulatory approvals. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: 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 or other parties 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 poor credit conditions; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; 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, extended shelf life or other factors; 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; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of our 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 the impact of changes in international funding sources and testing algorithms; loss or impairment of sources of capital; ability to meet financial covenants in agreements with financial institutions; ability to retain qualified personnel; exposure to 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 Company's Securities and Exchange Commission filings, including its registration statements, Annual Report on Form 10-K for the year ended December 31, 2009, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide 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.
CONTACT: OraSure Technologies, Inc. Investor Contact: Ronald H. Spair, Chief Financial Officer 610-882-1820 Investorinfo@orasure.com Zer0 to 5ive for OraSure Technologies Media Contact: Jennifer Moritz 917-748-4006 firstname.lastname@example.org