BEAVERTON, Ore., Jan. 14 /PRNewswire/ -- Epitope, Inc. (Nasdaq: EPTO) said its marketing partner, SmithKline Beecham Consumer Healthcare (NYSE: SBH) has announced two important developments with respect to Epitope's OraSure(R) HIV-1 antibody testing system. Today's edition of the Journal of the American Medical Association (JAMA) includes a study that shows OraSure is a highly accurate alternative to blood testing. Separately, the State of New York recently cleared OraSure for use by physicians in that state. JAMA Study Underscores Accuracy of Oral HIV Antibody Test Study Shows OraSure System to Be a Simple, Highly Accurate HIV Testing Option No Blood or Needles Required The study published today in JAMA shows that the OraSure HIV-1 Antibody Testing System, the first oral HIV antibody test, is a highly accurate alternative to blood testing. The study results are considered significant because of the many advantages associated with a non-invasive method of specimen collection for HIV testing. All other HIV testing systems rely on blood samples that require the use of needles or lancets. The OraSure HIV-1 System was cleared by the Food and Drug Administration (FDA) last June. The System is being marketed to health professionals by SmithKline Beecham Consumer Healthcare (SBCH). Epitope, Inc. developed the OraSure System and manufactures both the OraSure specimen collection device and the OraSure Western Blot Test Kit which is used to confirm positive screening results. Organon Teknika, a division of Akzo Nobel, manufactures the Vironostika HIV-1 ELISA screening test which it distributes to laboratories together with the OraSure Western Blot confirmatory test for use in the OraSure HIV-1 System. Though we have known for ten yews that antibodies against HIV-1 can be detected in the oral fluid of HIV-positive subjects, this is the first reliable method for gathering and testing oral samples," said John Fitchen, M.D., chief operating officer of Epitope Medical Products, who was a lead investigator and co-author of the JAMA article. "Our study demonstrates definitively that test results using oral samples obtained with OraSure are highly accurate, and that the OraSure system can be used in place of blood testing." The OraSure technology uses a sample called oral mucosal transudate (OMT), not saliva. OMT is obtained using a specially treated pad that is placed between the patient's gum and lower cheek for two minutes. The pad is then placed in a preservative and sent to a clinical laboratory, where it is tested for the presence of HIV antibodies, the same way blood samples are tested. A single sample is sufficient for the initial screening test and for confirmatory testing, if indicated. The study used specimens from 3,570 subjects collected at 11 geographically dispersed sites, including general medical and public health clinics, blood banks, and clinics for HIV and other sexually transmitted diseases. Subjects ranged in age from 13 to 80. The study measured the accuracy of the OraSure System by comparing results with true HIV-1 antibody status. The results showed that the OraSure system provided the correct result or would trigger appropriate follow-up testing in more than 99.9% of the cases (3569/3570). The study was a basis for FDA clearance of the OraSure Western Blot Test Kit in June 1996. "While the OraSure System is currently approved by the FDA for administration by a trained healthcare professional under the supervision of a physician, this technology may prove to be well suited for use as a home test in the future," said Dr. Fitchen. Because it does not rely on a fingerstick or other means to obtain a blood sample, OraSure should increase access To HIV testing and therefore to counseling and early therapeutic intervention. "The availability of this noninvasive alternative to blood testing has a number of important public health implications," said Donna Sturgess, director of diagnostic products, SBCH. "First, a system without needles or blood is inherently safer for healthcare workers than a test involving blood collection. Second, many people reluctant to undergo a blood test for HIV testing are willing to give an oral sample for this purpose. And, third, OraSure, which is portable and simple to use, requires minimal training, which means it can reduce health personnel costs." OraSure Oral HIV-1 Test Now Available in New York State Opportunity for Physicians to Expand HIV Testing with New Technology OraSure HIV-1 Antibody Testing System is now available to physicians in New York State, SBCH announced recently. The OraSure technology -- which does not require blood or needles -- provides a simple, highly accurate HIV testing option and represents the first major breakthrough with the potential to expand HIV testing in more than ten years. "New York leads America in AIDS-related deaths and illnesses. New York City has more than 15% of all cases, surpassing San Francisco, Miami, Philadelphia and Los Angeles combined," stated Richard Sadovsky, M.D., Associate Professor of Family Medicine, State University of New York Health Science Center at Brooklyn, and Past President, New York State Chapter, American Academy of Family Physicians. "Greater access to testing will help more New Yorkers learn their HIV status and enable them to take proactive steps to stay healthier longer." SmithKline Beecham Consumer Healthcare is a division of SmithKline Beecham, one of the world's leading healthcare companies that discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines, health-related consumer products and healthcare services including clinical laboratory testing, disease management and pharmaceutical benefit management. Organon Teknika, a division of Akzo Nobel, N.V. is active in hemostatis, bacteriology, and immunodiagnostics in more than 100 countries. An extensive range of healthcare products and automated test systems are provided to hospitals, blood banks, clinical, scientific and food-screening laboratories. Epitope is a biotechnology company that develops and markets medical diagnostic products through its Epitope Medical Products group and superior plants and related products through its Agritope group. Consumers and health professionals can receive detailed information about OraSure by calling toll-free, 888-ORASURE (672-7873), ext. 400. Information is also available through OraSure's home page at "www.orasure.com."
Source: EPITOPE Inc.
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