Printer Friendly

EPITOPE AWARDED SECOND U.S. PATENT FOR ORAL DIAGNOSTICS TECHNOLOGY, FILES RESPONSE TO FDA COMMENTS

EPITOPE AWARDED SECOND U.S. PATENT FOR ORAL DIAGNOSTICS TECHNOLOGY,
 FILES RESPONSE TO FDA COMMENTS
 BEAVERTON, Ore., April 23 /PRNewswire/ -- Epitope Inc. (AMEX: EPT) today announced that the U.S. Patent Office has issued a second patent relating to the company's OraSure(R) oral specimen collection device. The patent, entitled "Oral Collection Device and Kit for Immunoassay," covers a method and device for collecting immunoglobulins and other analytes from the oral cavity for immunological and other testing. It is a continuation in part of a prior U.S. patent which was filed in 1989 and issued in June 1991.
 "Issuance of this latest patent provides additional protection for the proprietary technology which has been the focus of our development efforts in recent years," said Adolph J. Ferro, president and chief executive officer. Ferro noted that OraSure has undergone extensive clinical testing in the United States and in several foreign countries to demonstrate its effectiveness in collecting oral samples for use in the detection of antibodies to the AIDS virus and that the Food and Drug Administration (FDA) has been reviewing a Premarket Approval Application (PMA) which seeks permission to market OraSure for professional use in the United States. The company recently filed a response to FDA comments regarding the PMA. The response addressed a number of subjects including, among other matters, sample stability under adverse conditions, the ability of insurance agents to collect samples and the effectiveness of the device in testing samples obtained from low-risk populations. Approval to export the device to 13 foreign countries has already been granted by the FDA.
 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- 4/23/92
 /CONTACT: Gilbert Miller 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:


SC-LM -- SE014 -- 2220 04/23/92 18:45 EDT
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:Apr 23, 1992
Words:337
Previous Article:SOUTHERN NATIONAL ACQUIRES PINEHURST S&L
Next Article:CONCORD RESOURCES GROUP SELECTS NEW EXECUTIVE


Related Articles
EPITOPE RECEIVES FDA RESPONSE TO PREMARKET APPROVAL APPLICATION
EPITOPE REPORTS FIRST-QUARTER RESULTS, RECENT DEVELOPMENTS
EPITOPE REPORTS SECOND-QUARTER RESULTS
EPITOPE FILES ADDITIONAL INFORMATION WITH FDA FOR ORASURE PREMARKET APPROVAL APPLICATION
EPITOPE ADOPTS ORASURE MANUFACTURING MASTER PLAN
EPITOPE RECEIVES ORASURE UPDATE FROM FDA
EPITOPE RECEIVES NEW PATENT ON ORAL SPECIMEN COLLECTION DEVICE; REINSPECTION OF FACILITIES ENDS
EPITOPE FILES RESPONSE TO FDA FORM 483
EPITOPE GRANTED SIXTH ORASURE PATENT FOR ORAQUICK DEVICE
SMITHKLINE BEECHAM'S CONSUMER HEALTH CARE DIVISION REACHES AGREEMENT WITH EPITOPE, INC. TO ENTER THE DIAGNOSTIC MARKET

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