AEGiS-PRn: Trinity Biotech Submits One-Step HIV Test for Physician's Office to FDA

Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.

Trinity Biotech Submits One-Step HIV Test for Physician's Office to FDA

PR Newswire, 19 December 1996.

DUBLIN, Ireland, Dec. 19 /PRNewswire/ -- Trinity Biotech (Nasdaq: TRIBY) today announced that it has submitted its Uni-Gold HIV test to the U.S. Food and Drug Administration (FDA). Trinity's Uni-Gold HIV test is a simple, easy to use, one-step test which has been submitted to the FDA for approval for use in a physician's office setting. Trinity's Uni-Gold HIV test is designed to be as simple to run and easy to interpret as a pregnancy test. The test utilizes one drop of serum, plasma or whole blood and the result can be read in ten minutes. No instrumentation is required and the Uni-Gold device can be stored at room temperature. This represents the first ever FDA filing of a one-step HIV test.

While the product is designed to be used in both a self-test (OTC) and physician's office setting, the current regulatory environment, while permitting home collection, does not allow self-testing. Therefore, this FDA submission is confined to use of the product in a physician's office setting or alternatively in medical clinics, emergency care settings and hospital laboratories. However, advances in therapeutics for HIV, growing societal acceptance of HIV and increasing patient autonomy are among the factors which in the opinion of the Company will eventually result in the approval of a one- step, home test available in the pharmacy. At the appropriate time Trinity would be well positioned to make a further submission for approval of this product in the OTC market.

Commenting on the announcement, Ronan O'Caoimh, CEO of Trinity, said, "The availability of a ten minute simple doctors' office HIV test, coupled with the proliferation of managed care programs will create a significant new market. The recent availability of home collection tests represents a major boost for HIV diagnostics and control of the disease. In the event of Trinity's test being approved, individuals wishing to ascertain their HIV status will have the choice of using a home collection test or visiting their doctor. Using the home collection test contains some inherent traumas, as in standing in a check-out line with an HIV test, piercing one's own skin to get a blood sample, and mailing the sample and waiting a week before one telephones a computer (if negative) or a counselor (if positive).

"Trinity contends that many will prefer a visit to a doctor, who will run the test in ten minutes. It is important to note that results of the home collection test have so far shown 99% negative results. If we assume the same percentage in doctors' offices, then 99% of individuals will have a clear mind after ten minutes."

The importance of early diagnosis of HIV infection cannot be overemphasized. According to the Centers for Disease Control about one third of people with AIDS are first tested when they have already progressed to the disease. That adds up to ten years of untreated HIV infection that may have been transmitted to others. If viral load is reduced early, progression to the disease can be delayed and life can be lengthened significantly.

Trinity Biotech is currently in discussion with a number of leading health care companies regarding the marketing and distribution of Uni-Gold HIV.

Trinity Biotech develops, manufactures and markets rapid tests for the clinical laboratory, point-of-care and over-the-counter markets.

CONTACT: Jonathan O'Connell of Trinity Biotech, 800-603-8076; or Robert Long of LongView Partners, 212-463-9733/ 15:19 EST

Keywords: HIV; PEOPLE WITH AIDS

961219
PR961233

Copyright © 1996 - 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 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. .