Printer Friendly

VIRAL TESTING SYSTEMS ANNOUNCES THAT THE FDA CLEARS IND FOR ITS HIV-2 AIDS CONFIRMATION TEST

 HOUSTON, Feb. 25 /PRNewswire/ -- Viral Testing Systems Corporation (AMEX: VTS) announced today that the U. S. Food and Drug Administration (FDA) has approved an IND to initiate U.S. clinical trials to evaluate its indirect immunofluorescense assay for HIV-2 antibodies, Fluorognost HIV-2 IFA. This assay system is technically similar to Fluorognost HIV- 1 IFA that was licensed on Feb. 5, 1992, but detects the West African variant of the AIDS virus. VTS has a strategic alliance with Waldheim Pharmazeutika (Vienna, Austria) who developed both tests.
 According to Detlev Baurs-Krey, chairman of the board and chief of regulatory affairs and new product development of VTS, about 7,500 Fluorognost HIV-2 tests will be administered in the next three months through blood centers and in reference laboratories as part of the clinical studies of the new test.
 The trials will be conducted at the Centers for Disease Control in Atlanta; the American Red Cross Transmissible Diseases Laboratory in Rockville, Md.; the South Florida Blood Center in Miami; the American Red Cross Blood Services in Syracuse, N.Y.; the Minnesota Department of Health in Minneapolis; and at Serologicals, Inc. at Clarkston, Ga. Another field trial will be conducted at an overseas site with a high incidence of HIV-2 infection.
 VTS expects to submit data from U.S. multicenter trials to the FDA Center of Biologics Research and Review by October 1993.
 The company believes that Fluorognost HIV-2 will show a performance equal to that of Fluorognost HIV-1, which is the only immunofluorescence assay ever licensed by the FDA. It is also the only FDA-approved test that has the dual capability for both screening and confirming for the HIV virus. Clinical studies of the HIV-1 version had shown a sensitivity equivalent to current screening tests, and a higher specificity than seen in Western blot systems.
 Recently VTS acquired the rights to distribute all of the diagnostic test products, HIV and non-HIV, developed by Waldheim in all the Western Hemisphere, Australia, New Zealand, Taiwan, China, Hong Kong and certain Asian and Mid East countries.
 -0- 2/25/93
 /CONTACT: Holly Vaughan, (investors) 713-228-1544, or Professor Detlev Baurs-Krey, (product development) 516-287-3739, both of Viral Testing Systems Corporation; or Dr. Hermann Mucke of Waldheim Pharmazeutika Ges.m.b.H., (technical and scientific), in Austria, 01143-1-319-1456/
 (VTS)


CO: Viral Testing Systems Corporation ST: Texas IN: MTC SU:

WB-TS -- NY051 -- 0414 02/25/93 13:12 EST
COPYRIGHT 1993 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Feb 25, 1993
Words:398
Previous Article:BROKERED CERTIFICATE OF DEPOSIT RATES GENERALLY DECLINED IN A LATEST PERIOD, SIA REPORTS
Next Article:GOLDEN EAGLE GROUP OPENING BRANCH IN LAREDO, TEXAS
Topics:


Related Articles
Improving the AIDS test: genetic engineers offer a new approach to AIDS-antibody testing.
TELECONCEPTS SAYS AIDS TEST MAY IDENTIFY NEW HIV STRAIN
THERMASCAN STOCKHOLDERS APPROVE MERGER WITH TELECONCEPTS
DISEASE DETECTION INTERNATIONAL FILES 'IND' APPLICATION WITH FDA SEEKING APPROVAL TO BEGIN FORMAL CLINICAL STUDIES FOR SEVEN-MINUTE AIDS TEST
DISEASE DETECTION INTERNATIONAL TO COMMENCE U.S.A. CLINICAL TRIALS OF SEVEN-MINUTE, SEROCARD(R) HIV-1, AIDS TEST UNDER FDA 'IND' SUBMISSION
TRINITY BIOTECH ANNOUNCES PRE-MARKET IND APPROVAL FROM FDA ON BLOOD- BASED RAPID AIDS DIAGNOSTIC TEST AND TRIALS OF SALIVA-BASED AIDS TEST
VIRAL TESTING SYSTEMS' JANUARY SALES OF HIV TEST BETTER THAN EXPECTED
NEW AIDS SCREENING TEST DETECTS VIRUS EARLIER Coulter to Offer Blood and Plasma Collection Centers p24 Antigen Assay
FDA ADVISORY COMMITTEE RECOMMENDS APPROVAL FOR ROCHE'S AMPLICOR HIV MONITOR TEST
Pittsburgh Firm Prepares to Set the Standard in Rapid HIV Testing.

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