Calypte Biomedical and Cambridge Biotech complete urine Western blot submission.BERKELEY, Calif.--(BW HealthWire)--March 17, 1997--Calypte Biomedical Corp. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CALY) announced today that it has completed the clinical trials requested by the U.S. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. regarding the use of a urine-based Western blot for HIV-1 antibodies. The Western blot is intended to be used as a specific, supplemental test on urines which are repeatedly reactive using Calypte's Urine HIV-1 EIA (Electronic Industries Alliance, Arlington, VA, www.eia.org) A membership organization founded in 1924 as the Radio Manufacturing Association. It sets standards for consumer products and electronic components. screening test. The EIA, also distributed by Seradyn Inc. (Indianapolis, Ind.) under the Sentinel tradename, was licensed by the FDA in August 1996. The data were submitted to the U.S. FDA today by Cambridge Biotech Corp. (Rockville, Md.), a wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. of bioMerieux Vitek Inc. Cambridge is the Western blot manufacturer exclusively licensed by Calypte to produce the urine-based Western blot. According to Jack Davis, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Calypte, "This submission is an important milestone toward the goal of screening and confirming HIV-1 antibodies using the same urine sample. This ability can make a significant contribution in the battle against HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome by encouraging HIV testing in people who have declined it in the past because they fear the discomfort of a blood draw. "The more widespread identification of individuals who are infected with HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. will allow earlier treatment and reduce the further spread of disease." A urine Western blot would make it possible to complete the HIV testing algorithm on the original urine sample, avoiding the current requirement for a blood follow-up in patients who test repeatedly reactive on the urine screen. "The Western blot will bring the promising potential of HIV testing with urine samples -- safety, convenience, accuracy and cost-effectiveness -- to reality," said Davis. Calypte Biomedical Corp. is a diagnostic product and service company developing urine-based diagnostic tests and services, including the first urine-based test for antibodies to HIV-1, the virus that causes AIDS. -0- This release contains forward-looking statements relating to Calypte Biomedical and the Calypte urine test for HIV-1. These forward-looking statements contain risks and uncertainties, which could cause actual results to differ materially from those projected. These and other risks relating to Calypte Biomedical are set forth in "Risk Factors" in the company's Prospectus filed with the Securities and Exchange Commission on July 29, 1996 as supplemented on Aug. 7, 1996. CONTACT: Calypte Biomedical Corp. Jack Davis, 510/814-8500 (president/CEO) John DiPietro, 510/814-8500 (CFO See Chief Financial Officer. ) or Cambridge Biotech Corp. Rebecca Leaper, 301/251-0800 (VP Operations) Brian Armstrong, 314/731-8500 (VP Finance) |
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