Subject: FDA Panel Urges Blood Banks to Test For Rare Strain of AIDS Virus by June 
Date: Published: 9/30/91 (73 lines)
Source:  Wall Street Journal.  Copyright Dow Jones & Co. Inc. 

    Technology & Health:
    FDA Panel Urges Blood Banks to Test
    For Rare Strain of AIDS Virus by June
    ----
    By Bruce Ingersoll
    Staff Reporter of The Wall Street Journal

    WASHINGTON -- A Food and Drug Administration advisory
 panel recommended requiring the nation's 2,500 blood banks to
 begin testing their blood supplies for a rare strain of AIDS
 virus by June 1.
    While the recommendation isn't binding, the agency is
 expected to follow the advice of its blood-products panel by
 adopting a mandatory testing rule "very soon," an FDA
 spokesman said.
    Such regulatory action would be a multimillion-dollar boon
 to Genetic Systems Corp., a Sanofi Inc. unit that holds the
 only government license to sell diagnostic kits designed to
 detect antibodies to the extremely rare human
 immunodeficiency virus Type 2, or HIV-2.
    Sanofi is a U. S. subsidiary of the French pharmaceuticals
 gian Elf Aquitaine, whose American depositary receipts closed
 Friday at $35.75, up 37.5 cents, on the New York Stock
 Exchange.
    Separately, the FDA approved the drug foscarnet for the
 treatment of AIDS patients with cytomegalovirus retinitis, an
 eye infection that can lead to blindness.  The drug will be
 marketed under the trade name Foscavir by Astra
 Pharmaceutical Products Inc., a Westborough, Mass., unit of
 the Swedish drug company Astra AB. It is the eighth drug
 approved for treatment of an AIDS-related condition, and the
 second for cytomegalovirus retinitis.
    The FDA advisory committee on blood products voted 8-0 on
 the issue of HIV-2 testing.  The medical consensus is that
 "HIV-2 doesn't pose a significant threat to the blood
 supply," said the agency spokesman, Bradford Stone.  "This
 step is being taken as a precautionary measure."
    For the short term at least, Genetic Systems is in a
 position to monopolize the HIV-2 segment of the $210 million
 U. S. market for blood and plasma testing.  Last year, the FDA
 licensed a Genetic Systems test specifically designed for
 HIV-2, and last week the agency gave the company the go-ahead
 to market the first combination test for detecting antibodies
 to both HIV-2 and the widespread HIV-1.
    "It means great things potentially for us," said Mark
 Sieczkarek, vice president of the Seattle-based company.
 "We're the only approved manufacturer.  We expect to double
 our revenue over next two years."
    FDA officials expect the new test to streamline testing
 procedures for blood banks and other institutions engaged in
 high-volume screening of blood and plasma, and to improve the
 overall safety of the U. S. blood supply.
    Genetic Systems, however, eventually may face competition
 in the HIV-2 diagnostic market.  In July 1990, Abbott
 Laboratories applied for an FDA license to market a
 combination test of its own.
    The approval of foscarnet will give AIDS patients with
 cytomegalovirus retinitis an alternative to ganciclovir,
 which was approved in June 1989.  Many patients can't take
 ganciclovir because of its adverse effects on blood-cell
 production.
    Foscarnet has been available since August 1990 to patients
 participating in studies sponsored by Astra Pharmaceutical.
 Some serious problems, including kidney damage and seizures,
 have been associated with the drug.

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