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OraSure Technologies Signs Agreement for Development of Counseling and Referral System for Home Use Rapid HIV Test Kit & Over-The Counter Sales
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Apr 2 2007, 6:00 AM EST
Business Wire press release
OraSure plans to ask the U.S. Food and Drug Administration for approval to sell OraQuick in outlets such as drug stores and supermarkets. So far, the product has been approved for only professional use by hospitals, doctor offices and clinics.
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 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(R) 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(R) 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(R) 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(R) 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(R) 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(R) 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(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 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.
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