BEAVERTON, Ore., April 21 /PRNewswire/ -- Epitope, Inc. (Nasdaq: EPTO) today announced that it has completed an agreement with Organon Teknika Ltd. of Dublin, Ireland, a subsidiary of Akzo Nobel, regarding Epitope's OraQuick(R) oral fluid rapid assay for the diagnosis of HIV. The agreement calls for Organon Teknika to collaborate with the company on the final development of the OraQuick product and to manufacture the initial pre-production lots of the device at its facilities in Dublin, Ireland. Epitope and Organon Teknika intend to negotiate a long-term manufacturing and supply agreement for this product on the successful completion of this development phase. OraQuick is a one-step, rapid-format oral specimen testing system designed to provide test results within ten minutes. The company believes that OraQuick has significant potential as a rapid test for professional use, and possibly as a home-based test for various other conditions in addition to HIV. A report from the Centers for Disease Control (CDC) noted that over 25 percent of people tested for HIV at publicly funded clinics did not return for their test results, and that rapid tests would enable health-care providers to supply definitive negative and preliminary positive results to patients at the time of testing, potentially increasing the overall effectiveness of counseling and testing. Organon Teknika has substantial expertise in the development and manufacture of similar lateral flow rapid tests, and has already begun work on the OraQuick project. Organon Teknika's U.S. subsidiary currently manufactures and distributes the HIV-1 screening test which is approved by the FDA to be used with Epitope's OraSure(R) oral fluid collection device, supplies the antigen used by Epitope to manufacture the Western blot HIV-1 confirmatory test and also distributes the Western blot product for Epitope. John W. Morgan, Epitope's president and CEO, commented, "Epitope is in the final stages of development of the OraQuick product, with pre-clinical trials expected to start within a month. The company considers OraQuick to be a significant new platform technology with potential application beyond HIV testing. We believe that a rapid-format oral fluid test has the potential to address problems presently associated with tests that do not provide immediate preliminary results and other rapid tests which rely on finger-stick blood testing." Epitope, Inc. is an Oregon-based corporation that develops and markets medical devices and diagnostic products. Its focus is on products that use oral fluid in the detection of HIV infection, with emphasis in the life insurance and public health markets, and drugs of abuse and other analytes. Statements in this press release about future sales levels or other future events or performance are forward-looking statements. The company's actual results could be significantly different. Factors that could affect results include the extent of future use of oral fluid testing with OraSure in the insurance industry or other key markets; loss or impairment of sources of capital; ability of the company to develop product distribution channels; ability of the company to develop new products; development of competing products; changes in international, federal or state law or regulations; uncertainties related to customers' and suppliers' ability to achieve year 2000 compliance; and loss of key personnel. Although forward-looking statements help to provide complete information about the company, readers should keep in mind that forward-looking statements are much less reliable than historical information.
Source: EPITOPE Inc.
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