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EPITOPE FILES ADDITIONAL INFORMATION WITH FDA FOR ORASURE PREMARKET APPROVAL APPLICATION

 BEAVERTON, Ore., March 17 /PRNewswire/ -- Epitope Inc. (AMEX: EPT) today announced that it has recently filed additional materials with the Food and Drug Administration (FDA) in support of the company's Premarket Approval application (PMA) to market its OraSure(R) oral specimen collection device for use in the detection of antibodies to the AIDS virus. The filing formalizes the company's response to issues discussed at the Dec. 18, 1992, meeting of the agency's Blood Products Advisory Committee and in subsequent meetings and discussions with FDA staff.
 "In our submission to the FDA, we addressed issues which must be resolved in order to gain approval of our OraSure PMA. The filing covers proposed labeling, a mechanism for confirmation of positive screening tests, procedures for subject counseling, and training of specimen collection personnel," said Adolph J. Ferro, president and chief executive officer. He noted that the FDA may take up to 180 days to review the submission, but that the company was hopeful for an expeditious response.
 Epitope Inc. is an Oregon corporation utilizing biotechnology to develop diagnostic products for the detection of AIDS and other indications and, through its agricultural unit, Agritope Inc., superior new plant varieties.
 -0- 3/17/93
 /CONTACT: Mary Hagen of Epitope, 503-641-6115/
 (EPT)


CO: Epitope Inc.; U.S. Food and Drug Administration ST: Oregon IN: MTC SU:

SW -- SE006 -- 7006 03/17/93 11:47 EST
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Publication:PR Newswire
Date:Mar 17, 1993
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