OraSure Technologies Commences Initial Studies for FDA Approval of Home Use Rapid HIV Test Kit
BETHLEHEM, Pa.--(BUSINESS WIRE)--Sept. 27, 2006--OraSure Technologies, Inc. (NASDAQ: OSUR), the market leader in oral fluid diagnostics and the manufacturer of the OraQuick ADVANCE(R) Rapid HIV-1/2 Antibody Test, announced today that it has commenced several laboratory-based operational studies as the initial stage of the process to obtain U.S. Food and Drug Administration ("FDA") approval of the OraQuick ADVANCE(R) test for use in the consumer or over-the-counter ("OTC") market in the United States.
These studies are part of a group of research and development protocols known as "stress" or "flex" studies that are designed to demonstrate the robustness of the OraQuick(R) test for home use. Specifically, the studies are designed to determine the impact of environmental and common household factors on the performance of OraQuick(R). Several of these studies were recently commenced and several more are expected to be started in the near future. These studies are in addition to those the Company previously performed when it obtained a CLIA (Clinical Laboratory Improvements Amendments Act of 1988) waiver for the OraQuick(R) test in 2005.
"We are extremely pleased to have started the initial studies to support our efforts to obtain FDA approval for an over-the-counter offering of our OraQuick(R) test," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "In addition to these laboratory-based stress studies, additional clinical studies are planned under amendments to an Investigational Device Exemption that we previously filed with the FDA. We look forward to continuing our work with the FDA and other members of the healthcare community to make a home use rapid HIV test available in the United States."
OraQuick ADVANCE(R) is the first and only FDA-approved and CLIA-waived rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in 20 minutes, using oral fluid, finger-stick or venipuncture whole blood or plasma specimens. The Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration have deployed over one million OraQuick(R) tests in various public health, drug treatment and outreach settings throughout the United States. The OraQuick(R) test is also used by hospitals, state departments of health, clinics, community-based organizations, and college/university health centers throughout the country.
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 collection devices and assays to the life insurance industry and public health markets for the detection of antibodies to HIV. In addition, the Company supplies oral fluid testing solutions for drugs of abuse testing. For more information on the Company, please go to www.orasure.com.
Important Information
This press release contains certain forward-looking statements including with respect to products, clinical studies and regulatory submissions and approvals. Actual results could be significantly different. Factors that could affect results include the ability to market and sell products; impact of competitors, competing products and technology changes; ability to develop, commercialize and market new products; market acceptance of oral fluid testing or other new products or technology; changes in market acceptance based on product performance; continued bulk purchases by customers, including governmental agencies, and the ability to fully deploy those purchases in a timely manner; changes in relationships 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 our products; 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; ability to obtain, and timing and cost of obtaining, necessary regulatory approval 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; 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; 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, patent infringement, 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 complete consolidation or restructuring activities; 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, 2005, 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.
CONTACT: OraSure Technologies, Inc.
Ronald H. Spair, 610-882-1820
Investorinfo@orasure.com
www.orasure.com
or
Zer0 to 5ive
Media:
Jennifer Moritz, 917-748-4006
jmoritz@0to5.com
SOURCE: OraSure Technologies, Inc.
