(BW) Saliva Hires Regulatory Affairs Director for FDA Campaign

(BW) Saliva Hires Regulatory Affairs Director for FDA Campaign

BUSINESS WIRE - 44 Montgomery St, 39th Floor, San Francisco, CA 94104; Tel: (415) 986-4422; FAX: (415) 788-5335 - Wednesday, 23 October 1996.

VANCOUVER, Wash.--(BUSINESS WIRE)--Oct. 23, 1996-- Company intends to file for US approval of rapid HIV tests, says CEO Medical diagnostic developer Saliva Diagnostic Systems Inc. (SDS) has begun a campaign for domestic approval of its rapid, non-laboratory HIV tests by hiring a regulatory affairs director to oversee submission of the tests to the U.S. Food and Drug Administration (FDA).

Tom Trotter, Regulatory Affairs Consultant and Manager formerly employed by Genetic Systems, Baxter Healthcare Corp. and SmithKline Instruments, will prepare the company for FDA review of the tests in 1997, said SDS President Ronald Lealos on Wednesday. Trotter will be a full-time employee of SDS, he added.

"Now is the time to act on FDA approval," said Lealos. "Rapid HIV tests are coming to the attention of the medical community and the general public as useful tools whose time has come. The Centers for Disease Control and Prevention recently concluded that developers of rapid HIV tests should be encouraged to apply for FDA approval and we are hopeful that the FDA will allow us take part in the Fast Track program for medical devices. With the advent of new treatments for HIV and AIDS, attitudes towards rapid HIV tests appear to have changed dramatically. SDS has the technology; our data and independent evaluations, some published in peer-reviewed journals, have demonstrated that our rapid HIV tests work as well as most approved lab tests. Now the political component seems to be improving our chances of approval.

"Mr. Trotter's experience in the regulatory field will also be valuable in submitting less controversial SDS products, such as Hema-Strip H.pylori, our rapid test to detect Helicobacter pylori, a bacteria that causes peptic ulcers," Lealos continued. "We believe most of the new products should qualify for 510(k) submission, a familiar field for Mr. Trotter."

Since graduating from San Jose State University in 1976, Trotter has worked as a Regulatory Affairs Manager with Cytran Inc., Genetic Systems Corp., and Baxter Healthcare Corp. He was a Regulatory Submissions Supervisor for Coopervision CILCO and a Supervisor of R&D Technical Services with Cetus Corp. He also worked as a Supervisor of Biochemical Production at SmithKline Instruments.

SDS products include Sero-Strip HIV-1/2, a serum-based HIV antibody test, and Hema-Strip HIV-1/2, an HIV antibody test that uses a drop of whole blood for analysis. Saliva-Strip HIV-1/2, which uses saliva as a diagnostic medium, is in the final stages of development. SDS is also developing a rapid test for H. pylori, an ulcer-causing bacteria. All of the tests provide results outside laboratory settings within a few minutes.

The company also sells Omni-SAL, a saliva collector used for HIV testing overseas, and Omni-Swab, a collection device used for DNA testing overseas, and other diagnostic devices.

CONTACT: Saliva Diagnostic Systems Inc. Joni O'Donahue, 360/696-4800

Keywords: HIV

Copyright (c) 1996/BUSINESS WIRE. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, Business Wire, 1185 Avenue of the Americas, 3rd Floor, New York, NY 10036; Tel: (212) 575-8822; FAX: (212) 575-1854.
961023
BW961025

Copyright © 1996 - Business Wire. All rights reserved. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Business Wire, Permissions Desk, Business Wire, 1185 Avenue of the Americas, 3rd Floor, New York, NY 10036; Tel: (212) 575-8822; FAX: (212) 575-1854. http://www.businesswire.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, the National Library of Medicine, Pacific Life Foundation and donations from users like you.

Always watch for outdated information. This article first appeared in 1996. 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, 1996. 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. .