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EPITOPE'S ORASURE PREMARKET APPROVAL APPLICATION SCHEDULED FOR REVIEW BY FDA ADVISORY PANEL

EPITOPE'S ORASURE PREMARKET APPROVAL APPLICATION SCHEDULED FOR REVIEW
 BY FDA ADVISORY PANEL
 BEAVERTON, Ore., Nov. 10 /PRNewswire/ -- Epitope Inc. (AMEX: EPT) today announced that the Food and Drug Administration (FDA) has scheduled an advisory panel meeting during which the company's Premarket Approval Application (PMA) to market its OraSure(R) oral specimen collection device for use in HIV-1 screening will be considered. The Blood Products Advisory Committee of the agency's Center for Biologics Evaluation and Research will meet in Rockville, Md., on Dec. 18.
 "We are pleased to have an opportunity to present the results of our OraSure clinical trials to the advisory panel," said Adolph J. Ferro, president and chief executive officer. Ferro noted that the panel reviews provide the FDA additional input for use in the approval process, but that panel recommendations are advisory only and not binding.
 The company commenced OraSure clinical trials in the fall of 1990 and submitted its initial PMA to the FDA in May 1991. In November 1991, the agency requested additional information with respect to the PMA. The requested information was forwarded to the FDA in April 1992. Since that time, the company has continued to work closely with the FDA staff in completing the review process.
 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- 11/10/92
 /CONTACT: Mary Hagen of Epitope, 503-641-6115; or Shari Annes of Annes Associates, 415-726-5400, for Epitope/
 (EPT) CO: Epitope Inc.; U.S. Food and Drug Administration ST: Oregon IN: MTC SU:


SW-JH -- SE004 -- 9295 11/10/92 12:46 EST
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Publication:PR Newswire
Date:Nov 10, 1992
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