Subject: Epitope Halts Distribution Of Saliva-Based AIDS Test
Date: Published: 7/2/91 (34 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Technology Brief -- Epitope Inc.:
    Concern Halts Distribution
    Of Saliva-Based AIDS Test

    Epitope Inc. said it halted distribution of its
 saliva-based AIDS test to insurance companies after a clash
 with the Food and Drug Administration.
    Epitope, based in Beaverton, Ore., hasn't received
 clearance to market the OraSure test generally.  Nonetheless,
 it began distributing it in January for use by insurers
 through Home Office Reference Laboratory Inc., Lenexa, Kan.,
 on the theory that the FDA has permitted limited marketing of
 unapproved tests to insurers in other cases.  For its second
 quarter ended March 31, Epitope reported OraSure-related
 revenue of $700,000.
    But the FDA said in a letter to Epitope that its reliance
 on the other cases was "unwarranted."  It ordered the company
 and Home Office to pull distribution immediately, and to
 issue a notice that the device hasn't received FDA approval.
    Epitope said it complied with the request.  Gilbert Miller,
 executive vice president and chief financial officer, said
 the test had been used by insurers for prescreening
 applicants, and that a standard blood test for the AIDS virus
 was conducted if the test was positive.
    In American Stock Exchange trading yesterday, Epitope
 closed at $15, down $3.50.

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