BETHESDA, Md. -- Two combination blood tests for detectingboth HIV-1 and HIV-2 were unanimously recommendedThursday for approval by the Food and Drug Administration'sBlood Products Advisory Committee.

The tests were developed by Seattle-based Genetic SystemsCorp. and Abbott Laboratories of Abbott Park, Ill.

U.S. blood donations are now screened only for HIV-1 (humanimmunodeficiency virus), which is the major cause of AIDS inthe United States. HIV-2 is responsible for most AIDS cases inWest Africa. The FDA said last spring that the widespreadscreening of blood for HIV-2 was unnecessary because of thefew reported cases in the United States.

The number of U.S. cases of HIV-2 infection reported to theCenter for Disease Control has since risen to 24. The FDA is nowkeen on combination testing, said Jay Epstein, acting deputydirector for the FDA's division of transfusion science.

"We should get the products to the user as soon as possible,"said Girish Vyas, advisory committee chairman.

Jeffrey McCullough, senior vice president for biologicalmedicine for the American Red Cross, urged the FDA "to act asexpediently as possible" to approve the combination kits formarketing. His organization, a major source of blood donated inthe United States, is "strongly considering" HIV-2 testing of allblood.

With 25 million units of blood gathered annually by bloodbanks and plasma centers, a combination test could have amarket of about $40 million to $50 million, said Robert Shea ofGenetic Systems, a unit of France's Sanofi S.A.

Genetic Systems' HIV-1 test kit, approved in 1986, holds a 20percent market share. Abbott's HIV-1 test, approved in 1985,indisputably leads both U.S. and world markets. Abbott hasmarketed its combination test in Europe since last year.

Scientists from both companies told the advisory committeethat their combination tests were as sensitive to HIV-1 as thesingle tests. Several European nations that import U.S.-sourcedblood and blood products are pressuring blood banks to test forHIV-2, Epstein said.

-- Rachel Nowak BioWorld Staff

(c) 1997 American Health Consultants. All rights reserved.