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| |  New AIDS Test Cleared by FDA To Screen Blood Supply for HIV Antigen ABBOTT PARK, Ill., April 24, 1996 -- Abbott Laboratories (NYSE: ABT) today announced the United States Food and Drug Administration (FDA) has cleared for marketing the company's new test for the virus that causes AIDS. The test is intended for the detection of the HIV-1 p24 antigen of the human immunodeficiency virus (HIV). The test, to be sold under the name Abbott HIVAG-1 Monoclonal, is an enzyme immunoassay (EIA), and is the second FDA-licensed HIV antigen detection kit intended for use in blood banks and plasma centers nationwide according to new FDA blood screening recommendations. Abbott HIVAG-1 Monoclonal is also cleared for prognostic use in HIV-infected patients. "The test reduces the 'window' period between HIV infection and detection -- the first 25 to 45 days, when the virus can elude efforts to screen it out," said Ronald Gilcher, M.D., president and CEO, Sylvan N. Goldman Center, Oklahoma Blood Institute, where the test has been researched since 1991. "The new test also cuts testing time to four hours from 24 from Abbott's earlier version antigen test." HIV antibody testing has been used by all U.S. blood institutions to screen donated blood and plasma for HIV infection. This new test will allow U.S. blood screening centers to have an alternate source for the p24 antigen test. (HIV antibody tests will continue to be used in parallel to identify HIV positive blood.) While antibody testing can measure the body's immune response to the presence of a virus, antigen testing detects the virus itself. Patients infected with HIV may have positive antigen results very early in the infection -- before a substantial antibody response has formed. As a result, people recently infected with HIV may be identified by the antigen test while the antibody test remains negative or indeterminate until a later date. "This new antigen test demonstrates Abbott's ongoing commitment to help improve the safety of the world's blood supply and reduce the spread of diseases such as AIDS," said Miles D. White, senior vice president, diagnostics operations at Abbott. "We believe that the timely and specific detection of HIV infection made possible by Abbott HIVAG-1 Monoclonal EIA can be applied to help prevent the spread of AIDS through blood products and be used as a prognostic indicator." Each year, approximately 4 million Americans receive transfusions of blood and blood components derived from 12 million units of blood, from more than 8 million donors. Much of this blood, and an additional 12 million units of plasma, is further processed into treatment products, such as clotting factor for people with the blood disorder hemophilia. Last year, the FDA's Blood Products Advisory Committee concluded that the antigen screening tests appeared to be somewhat effective in narrowing the HIV window, and in August 1995, FDA recommended that U.S. blood banks begin screening blood for the HIV antigen within three months of FDA licensing a product intended for blood screening. "We must continue to pursue advances that maximize the safety of our blood supply," said Dr. Gilcher. "Good science, coupled with sound leadership, can help us achieve that goal." The Abbott HIVAG-1 Monoclonal EIA test was developed and is marketed by Abbott Laboratories. In 1985, the company was the first to market an AIDS antibody test and, since 1989, has been the only firm with an FDA licensed HIV antigen test -- HIVAG-1 -- a polyclonal-based test intended for diagnostic or prognostic use and not intended for screening blood donors. Abbott Laboratories, a leading supplier of hepatitis and HIV diagnostic tests, is a worldwide manufacturer of health care products, employing 50,000 people. In 1995, the company's sales and net earnings were $10.0 billion and $1.7 billion, respectively, with earnings per share of $2.12.
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