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EPITOPE RECEIVES FDA RESPONSE TO PREMARKET APPROVAL APPLICATION

    EPITOPE RECEIVES FDA RESPONSE TO PREMARKET APPROVAL APPLICATION
    BEAVERTON, Ore., Nov. 13 /PRNewswire/ -- Epitope Inc. (AMEX: EPT) announced today that it received a response from the Food and Drug Administration (FDA) to its application for premarket approval (PMA) of its OraSure(R) oral specimen collection device.  The application, which was filed in May 1991, seeks permission to market OraSure for use in the detection of antibodies to the AIDS virus.
    "The FDA has done a fair and thorough review of our PMA.  The FDA response requests clarification and amplification of certain information presented in our application," said Adolph J. Ferro, president and chief executive officer.  He noted that the company has already commenced discussion with FDA staff regarding the response. The company is confident that all issues raised by the FDA will be resolved satisfactorily.
    Epitope Inc. is an Oregon corporation utilizing biotechnology to develop diagnostic tests for AIDS and other indications, therapeutic antimicrobial drugs and, through its agricultural unit, Agritope Inc., superior new plant varieties.
    -0-                        11/13/91
    /CONTACT:  Mary Hagen of Epitope, 503-641-6115; or Shari Annes of Annes Associates, 415-726-5400, for Epitope/
    (EPT) CO:  Epitope Inc. ST:  Oregon IN:  MTC SU: LM-SC -- SE012 -- 4196 11/13/91 18:42 EST
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Publication:PR Newswire
Date:Nov 13, 1991
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