First urine test for HIV-1 antibodies licensed by U.S. Food and Drug Administration.WASHINGTON--(BUSINESS WIRE)--Aug. 6, 1996--Calypte Biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. Corp., a Berkeley, Calif.-based diagnostic research and development company Tuesday received notification from the 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. of the licensure of its diagnostic test for the detection of antibodies to HIV-1 in urine. "We are extremely pleased that years of research and development efforts have finally come to fruition. We have always believed that more convenient diagnostic tools will lead to better treatment and care," said Dr. Howard Urnovitz, Calypte's founder and chief science officer. As licensed by the FDA for professional use, the test, under the product names "Calypte(TM) HIV-1 Urine 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. " or Seradyn "Sentinel(TM) HIV-1 Urine EIA" (an enzyme immunoassay Immunoassay An assay that quantifies antigen or antibody by immunochemical means. The antigen can be a relatively simple substance such as a drug, or a complex one such as a protein or a virus. for the detection of antibodies to Human Immunodeficiency Virus human immunodeficiency virus n. HIV. Human immunodeficiency virus (HIV) A transmissible retrovirus that causes AIDS in humans. type 1 (HIV-1) in urine), will be available to physicians in public health clinics, hospitals and doctors' offices. In order to be tested, patients will simply provide a urine specimen in a plastic cup identical to those cups used in medical facilities worldwide and give it to the attending physician who orders the test from a clinical laboratory. "Getting tested for HIV-1 frequently and early in the infection cycle is critical in slowing its spread and improving the disease-free survival disease-free survival Oncology The time that a person with a disease lives without known recurrence; DFS is major clinical parameter used to evaluate the efficacy of a particular therapy, which is usually measured in 'units' of 1 or 5 yrs. See Cure, Remission. period. This is particularly important now that new therapeutic options exist, which allow us to reduce the viral load in early diagnosed cases and, hopefully, extend the time between infection with HIV-1 and the onset of disease," said Alvin Friedman-Kien, M.D., a New York University New York University, mainly in New York City; coeducational; chartered 1831, opened 1832 as the Univ. of the City of New York, renamed 1896. It comprises 13 schools and colleges, maintaining 4 main centers (including the Medical Center) in the city, as well as the medical school professor, member of the company's Scientific Advisory Board and the discoverer of antibodies to HIV-1 in urine. "Calypte's urine test could become a significant weapon in the battle to slow the AIDS epidemic because it makes testing safer, easier and more accessible compared to traditional methods," said Darrel Cummings, deputy executive officer of the Los Angeles Gay and Lesbian Community Services Center, the country's largest anonymous HIV testing center. "The test does not require legions of specially trained medical workers, as the process involves obtaining a sample of urine, the most widely tested bodily fluid. Also, the elimination of needles creates a safer and less intimidating environment," he added. Dr. Luc Montagnier, discoverer of HIV-1 and member of Calypte's Scientific Advisory Board said, "This test holds particularly important promise for developing countries desperately trying to control the spread of AIDS and where access to specially trained health professionals and clean needles for drawing blood is not always available." "This FDA notification will allow us to make a significant contribution in the fight against AIDS. Above all, it is this part of our accomplishment that we find most rewarding," said Jack Davis, president and chief executive officer of Calypte. Calypte Biomedical Corp. is a Berkeley-based health care company dedicated to the development and commercialization of urine-based diagnostic products and services for HIV-1, sexually transmitted diseases Sexually transmitted diseases Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely and other chronic illnesses. CONTACT: Calypte Biomedical Corp. Jack Davis, president, 510/814-8505 or John DiPietro, CFO See Chief Financial Officer. , 510/814-8503 |
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