Subject: Abbott Labs Receives First U. S. License For Aids Test to Screen Blood Date: Published: 3/4/85 116 lines Source: Wall Street Journal (c) copyright Dow Jones Inc. Abbott Labs Receives First U. S. License For Aids Test to Screen Blood Donors --- By Marilyn Chase and Joe Davidson Staff Reporters of The Wall Street Journal Abbott Laboratories received the first government license to produce and sell a test aimed at reducing the risk of Acquired Immune Deficiency Syndrome being spread by blood transfusions. At a news conference Saturday, Margaret Heckler, secretary of health and human services, said a positive reaction to the test would mean "there are antibodies in the blood from the virus that causes AIDS. " The presence of those antibodies would exclude blood or plasma donations. The government approval follows months of controversy, pitting blood-bank officials, who generally view the test as a promising means of detecting infected blood, and gay-rights activists, who are alarmed by what they see as a civil-rights threat. Abbott, based in North Chicago, Ill., began distributing the test immediately after approval was announced, said David Jones, vice president, public affairs. There are 2,300 blood banks and plasma centers in the U. S. Four other concerns have applications before the Food and Drug Administration to make and market test kits. Mrs. Heckler said another application is expected to be approved by the end of this week and a third by the end of next week. First identified in 1981, AIDS is a viral disease that ravages the body's immune system, exposing it to so-called "opportunistic infections," including rare varieties of pneumonia and cancer, that usually result in death. A recent report said the epidemic has struck 8,215 people, killing 3,921. New cases may more than double again this year, according to the Centers for Disease Control in Atlanta. Last April, Robert C. Gallo of the National Cancer Institute announced the isolation of a virus, HTLV-III, as the probable cause of AIDS. The U. S. Public Health Service licensed five companies, Abbott Labs among them, to produce the blood test. Since then, the government program has been surrounded in controversy. Some critics have said the test would add to the confusion about the disease, because in some cases a "positive" result will be wrong. In addition, the National Gay Task Force has urged homosexuals not to take the test, which it says could be the basis for job or insurance discrimination. Promiscuous homosexuals, Haitians and intravenous drug users have been the groups in which AIDS has occurred most often. At the news conference, Mrs. Heckler and Frank Young, Food and Drug Administration commissioner, stressed that the test isn't a diagnostic tool to determine if a person has AIDS. While calling the test a "highly reliable" one that detects the antibody in the blood of 93% to 99% of those who have it, Dr. Young said, "It's just simply not true" that a "positive" reaction to the test means a patient has the disease. Dr. Young said "false positive" indications will occur about 17 times out of every 100 persons who test positive. However, the 17 will represent less than 1% of everyone who takes the test, he said. S. Gerald Sandler, an associate vice president of the American Red Cross, called the government approval a major advance that will ensure the blood supply is "very safe." He said the Red Cross would use the Abbott test for all of its donor screening. The Red Cross, he said, collects about half of the 12 million units of blood taken in the nation each year. In San Francisco and New York -- the nation's two major AIDS epidemic centers -- blood-bank directors cautiously cheered the FDA's approval, despite lingering reservations about possible false-positive and false-negative test results. Mervyn Silverman, a consultant to San Francisco's health department, said, "The test indicates that your immune system has been exposed to the virus and has raised troops (i.e. antibodies) to fight it. It doesn't tell you whether the troops were successful or unsuccessful." Dr. Silverman described the test as "very sensitive and very specific for blood," adding his information was that the Abbott test has about 99% accuracy -- both as to sensitivity and specificity. Homosexual activists rallied Saturday in San Francisco urging their numbers to shun the test. "The Reagan administration intends to make and keep lists of gay and bisexual men who take the test," warned a press release distributed Saturday by a group calling itself Mobilization. In New York, Johanna Pindyck, director of the Greater New York Blood Center, said: "As the largest blood center in the U. S., we welcome the introduction of testing. Because the test is expected to add a measure of safety to the blood supply, we expect to use it." Brian McDonough, executive director of the Irwin Memorial Blood Bank in San Francisco said that, because of the disease's long incubation period, it will be years before the antibody test makes a dent in the incidence of transfusion-AIDS, currently running at about 1% of total AIDS cases. Abbott Labs' Mr. Jones said each of the company's kits would sell for $2 or $3, but he wouldn't disclose the market share or profit his company hopes to achieve. Electro-Nucleonics Inc., Columbia, Md., is expected to have a test approved soon. The other companies seeking approval are Litton-Bionetics Inc., Kensington, Md.; Travenol-Genentech Diagnostics, Cambridge, Mass., and Du Pont Co., Wilmington, Del., with Biotech Research Laboratories Inc., Rockville, Md. (This article is made available here by Dow Jones Co. for the personal and non-commercial use of callers to this bbs, in the hope that it will be of some help to those who are suffering from the disease and others who are seeking to help them.)