Printer Friendly

FDA ADVISORY PANEL SPLIT ON EPITOPE PMA

 BEAVERTON, Ore., Dec. 18 /PRNewswire/ -- Epitope Inc. (AMEX: EPT) today announced that a Food and Drug Administration (FDA) advisory panel reached a split decision in its consideration of the company's Premarket Approval application (PMA) for sale of its OraSure(R) oral specimen collection device for use in detection of antibodies to the HIV-1 virus.
 "We are encouraged that the Blood Products Advisory Committee and the FDA recognize that OraSure offers unique advantages over blood collection in facilitating HIV antibody screening. The committee raised issues related to collection settings, sample verification and product labeling, and we are confident that these issues can be satisfactorily resolved. We will work closely with the FDA toward that end," said Adolph J. Ferro, president and chief executive officer.
 Epitope Inc. is an Oregon corporation utilizing biotechnology to develop diagnostic tests for AIDS and other indications and, through its agricultural unit, Agritope Inc., superior new plant varieties utilizing proprietary technology.
 -0- 12/18/92
 /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-LA -- SE021 -- 8490 12/18/92 22:25 EST
COPYRIGHT 1992 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Dec 18, 1992
Words:197
Previous Article:ALCOA SETS CHARGES AGAINST 1992 EARNINGS
Next Article:FRITZ ANNOUNCES ELECTION OF OUTSIDE DIRECTORS
Topics:


Related Articles
EPITOPE REPORTS SECOND-QUARTER RESULTS
EPITOPE'S ORASURE PREMARKET APPROVAL APPLICATION SCHEDULED FOR REVIEW BY FDA ADVISORY PANEL
MOLECULAR BIOSYSTEMS INC. SUBMITS PMA AMENDMENT TO FDA
EPITOPE FILES ADDITIONAL INFORMATION WITH FDA FOR ORASURE PREMARKET APPROVAL APPLICATION
EPITOPE FILES RESPONSE TO FDA FORM 483
ATL'S BREAST ULTRASOUND PMA APPLICATION SCHEDULED FOR FDA PANEL HEARING
FDA NOTIFIES EPITOPE ORAL HIV CONFIRMATORY TEST IS APPROVABLE
Urologix, Inc. PMA Satisfies FDA Initial Review

Terms of use | Copyright © 2016 Farlex, Inc. | Feedback | For webmasters