OraQuick Rapid HIV-1 Antibody Test is Honored for Innovation with 2003 Circle of Excellence Award
BETHLEHEM, Pa., Jan 26, 2004 (BUSINESS WIRE) -- OraSure Technologies, Inc. (Nasdaq NM:OSUR), the market leader in oral fluid diagnostics, announced today that its OraQuick(R) Rapid HIV-1 Antibody Test has received the prestigious 2003 Photonics Circle of Excellence Award. This Award is bestowed annually on the 25 most technically innovative new products of the year, as judged by members of the Photonics Spectra magazine Editorial Advisory Board. The award was announced today at the Photonics West Conference in San Jose, California.
OraQuick(R) is a rapid, point-of-care test designed to detect antibodies to HIV-1 within 20 minutes. OraSure has received FDA approval for use of the OraQuick(R) device in testing finger-stick and venipuncture whole blood specimens for antibodies to HIV-1. In addition, OraSure has received a CLIA (Clinical Laboratory Improvement Amendments of 1988) waiver for this test, thereby permitting the test to be used in more than 180,000 sites in the United States, such as outreach clinics, community-based organizations and physicians' offices.
The products competing for the Circle of Excellence Awards were judged on excellence, innovation and achievement by the magazine's Editorial Advisory Board. The Board is comprised of internationally recognized experts in a variety of photonics disciplines.
"This award further validates the successful collaborative efforts of our research and development, manufacturing, regulatory and quality groups, who were responsible for bringing the OraQuick(R) Rapid HIV-1 test to the market," said Mike Gausling, Chief Executive Officer of OraSure Technologies. "OraSure has a long history of innovation in the diagnostics field, which we expect to continue with the FDA approval of oral fluid, plasma and HIV-2 claims for OraQuick(R) anticipated this year."
The 2003 Photonics Circle of Excellence winners were honored at a ceremony during the Photonics West Conference held January 24 through 26 at the Fairmont Hotel in San Jose, California. Photonics Spectra is published monthly by Laurin Publishing in Pittsfield, Mass.
Photonics is the technology of generating, harnessing and manipulating light to perform useful functions for a wide variety of purposes, including light emission, transmission, deflection, amplification and detection. The range of applications of photonics extends from energy generation to detection to communications and information processing. The OraQuick test utilizes photonics technology as a component of its test interpretation process.
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-1. 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 regulatory submissions and approvals. Actual results could be significantly different. Factors that could affect results include the ability to market products; impact of competitors, competing products and technology changes; ability to develop, commercialize and market new products; market acceptance of oral fluid testing products and up-converting phosphor technology products; ability to fund research and development and other projects and operations; ability to maintain new or existing product distribution channels (including our ability to implement a direct sales effort or other alternative distribution for OraQuick(R)); reliance on sole supply sources for critical product components; availability of related products produced by third parties; ability to obtain and timing of obtaining necessary regulatory approvals; 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; ability to obtain licenses to patents (including HIV-2 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 and other types of litigation (including the outcome of our dispute with Abbott Laboratories); changes in international, federal or state laws and regulations; changes in relationships with strategic partners and reliance on strategic partners for the performance of critical activities under collaborative arrangements; changes in accounting practices or interpretation of accounting requirements; 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, 2002, 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.
SOURCE: OraSure Technologies, Inc.
OraSure Technologies, Inc. Investor Contact: Ronald H. Spair, 610-882-1820 Investorinfo@orasure.com www.orasure.com or Media Contact: William Bruckner, 610-882-1820 wbruckner@orasure.com
