AEGiS-PRn: Sanofi Diagnostics Pasteur Offers Laboratories Improved HIV-1/HIV-2 Test Licensed by U.S. Food & Drug Administration

Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.

Sanofi Diagnostics Pasteur Offers Laboratories Improved HIV-1/HIV-2 Test Licensed by U.S. Food & Drug Administration

PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Monday August 25 2:05 PM EDT

REDMOND, Wash., Aug. 25 /PRNewswire/ -- A new, improved version of a specific test for the detection of antibodies to both HIV-1 and HIV-2 viruses in human blood and plasma has been licensed by the U.S. Food and Drug Administration (FDA). It is being made available immediately to blood banks and testing laboratories by Sanofi Diagnostics Pasteur's Genetic Systems Corporation.

"We believe this new test will enhance processing of donated blood and plasma, and enable more widespread testing for HIV-2, which has been only recently recognized as a public health risk in the U.S.," says Reed Simmons, Vice President and General Manager of Genetic Systems. "The new technology is in a microplate format suitable for laboratory automation," he adds. "I believe this will be an important product for HIV testing laboratories."

Genetic Systems' HIV-1/HIV-2 Peptide EIA, is an enzyme immunoassay which uses patented, specifically chosen synthetic peptides to detect antibodies to HIV viruses in the patient's blood or plasma. HIV is the cause of AIDS (Acquired Immunodeficiency Syndrome).

"The Peptide EIA provides both improved sensitivity and specificity for detecting HIV-1 and HIV-2," said Patrick F. Coleman, Ph.D., Director of Biologics Development. "Furthermore, this test maintains a broad reactivity with diverse sub-types of HIV-1 and HIV-2." The broad reactivity of the test is achieved by combining the most immunodominant synthetic peptide epitopes derived from the 'env' and 'pol' gene products for both HIV-1 and HIV-2, according to Dr. Coleman.

The new, improved test, which will be utilized as a screening test in blood banks and plasma centers, as well as in public health settings and hospitals, is validated for use on Sanofi Diagnostics Pasteur's microplate instrument platforms and can be added to existing systems. The test was researched and developed by Genetic Systems Corporation, located in Redmond, Washington, and represents an advancement over the company's currently available HIV-1/HIV-2 test.

There are between one and two million people in the United States believed to be infected with HIV, predominately HIV-1. The number of HIV infected persons is increasing at a rate of nearly five percent each year. HIV is a blood-borne virus transmitted primarily by unprotected sex or shared use of intravenous needles.

Sanofi Diagnostics Pasteur (800-424-9117) researches, develops and markets 'in vitro' diagnostic tests and systems for the detection of a variety of human diseases and allergies. It is a subsidiary of the global healthcare company, Sanofi.

SOURCE: Sanofi Diagnostics Pasteur

Copyright (c) 1997/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
970825
PR970816

Copyright © 1997 - PRNewswire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through PRNewswire, Permissions, 810 Seventh Ave., 32nd Floor, New York, NY 10019 http://www.prnewswire.com.

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Broadway Cares/Equity Fights AIDS, Elton John AIDS Foundation, National Library of Medicine, and donations from users like you.

Always watch for outdated information. This article first appeared in 1997. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 1997. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .