OraSure Technologies, Inc. (NASDAQ: OSUR), the market leader in oral fluid diagnostics and the manufacturer of the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test, announced today that it has signed an agreement with Constella Group LLC, to design and develop a telephonic and Internet accessible consumer counseling and referral system for use with the Company’s OraQuick ADVANCE® test in the consumer or over-the-counter (OTC) market. Constella is a leading provider of professional health services on a global basis and for the past five years has operated the Centers for Disease Control and Prevention (“CDC”) nationwide HIV/AIDS clearinghouse and call center.
During the past year, the Company has been conducting clinical studies and developing new packaging and labeling as it prepares to submit an application to the U.S. Food and Drug Administration (“FDA”) for approval of the OraQuick ADVANCE® test for use in the United States OTC market. A critical component of the clinical development of this product will be the incorporation of a consumer counseling and referral system.
Under the announced agreement, Constella will develop a robust counseling and referral system that is fully portable and compliant with both FDA and international regulatory and quality standards. The system will offer phone and website access 24 hours per day, 7 days per week to assist consumers who use the OraQuick® test and will provide medical referrals to consumers when needed.
“We have initiated design work on a consumer counseling and referral system and are pleased to have Constella on board to complete the process,” said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. “With their extensive experience in professional health services, and in particular their experience in international markets and in designing and operating the CDC’s HIV/AIDS call center here in the U.S., Constella is ideally suited to help develop a robust, state-of-the-art and fully compliant consumer counseling and referral system. We look forward to completing the development of a prototype system which will be validated and included in our clinical studies for OTC approval of our OraQuick ADVANCE® test by the FDA.”
“Constella is honored to apply our expertise in call center development and HIV/AIDS to support OraSure’s launch of this innovative, new technology making it easier for people to learn their HIV status,” said Chris LeGrand, president of Constella’s public sector business. “Like OraSure, we are committed to helping individuals both understand their HIV test results and receive immediate information on accessing life-saving treatment and care services.”
As previously announced, the Company has completed laboratory-based operational or “flex” studies and independent label comprehension studies as preliminary steps towards obtaining FDA approval of an over-the-counter OraQuick ADVANCE® HIV test. This clinical work will continue throughout 2007 and into 2008, after which the Company plans to submit a premarket application for FDA approval as soon as possible.
OraQuick ADVANCE® is the first and only FDA-approved and CLIA (Clinical Laboratory Improvements Amendments of 1988) waived rapid, point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in twenty minutes, using oral fluid, fingerstick or venipuncture whole blood, or plasma specimens. The CDC and the Substance Abuse and Mental Health Services Administration have deployed over one million OraQuick® tests in various public health, drug treatment and outreach settings throughout the United States. The OraQuick® 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 in vitro diagnostic assays to the employment, criminal justice, drug treatment, life insurance and public health markets for the detection of abused drugs and the antibodies to HIV. Based in Bethlehem, Pa., the company develops, manufactures and markets oral specimen collection devices, in vitro diagnostic tests, and other medical devices. For more information on the Company, please go to www.orasure.com.
About Constella Group LLC
Constella Group is a leading provider of professional health services worldwide, dedicated to enhancing human health around the world, every day. Through its work in health sciences, international development, and pharmaceutical product development, Constella creates and provides health intelligence to help industry and government clients identify and solve critical problems affecting human health. The company's 1,200 employees serve clients from company headquarters in Durham, N.C., from U.S. offices in Research Triangle Park, N.C.; Washington, D.C; Rockville and Frederick, Md.; Glastonbury, Conn.; Atlanta; and Morgantown, W.Va., from U.K.-based offices in Bath, Oxford and Cambridge; from offices in Cologne, Germany; Paris, France; and New Delhi, India; and from client sites and other offices across the world. For more information, visit www.constellagroup.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; 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 competitors, competing products and technology changes; 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; 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; 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, 2006, 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.
