Important note: Information in this article was accurate in 2003. The state of the art may have changed since the publication date.
PRNewswire - December 29, 2003
The product is approved for the detection of antibodies to HIV in human serum, plasma or whole blood and is the first and only device to be approved for use with all three sample types. Uni-Gold Recombigen(TM) HIV is simple to use, requiring only one step and produces a result within 10 minutes, whereas with conventional laboratory tests for HIV, results may not be available for hours or even days. Uni-Gold Recombigen(TM) HIV was approved by the FDA on the basis of clinical trial results on over 9,000 patient specimens where the product demonstrated a test sensitivity of 100% and a specificity of over 99.7%.
Commenting on the FDA approval, Ronan O'Caoimh, CEO said: "We are delighted to receive FDA approval of our Uni-Gold HIV Test. Our decision to apply for approval to market the product utilising three sample types is vindicated as we are now able to enter all market segments of significance in the US."
"Uni-Gold HIV has become the Gold Standard in the fight against Aids in Africa. Given this experience Trinity clearly has the production capability to meet the expected demand in the US for this product. We will market the product in the US using our own direct sales force. In anticipation of approval we have been building our US sales and marketing team and recently announced the hiring of Dr Philippe Gadal, previously head of Stago, to spearhead our efforts."
"Approx. 800,000 needle stick injuries occur in US hospitals each year requiring an immediate serum/plasma HIV test. In addition approx. 200,000 at risk pregnant women present at hospitals and require a rapid HIV test each year. The multi step SUDS(TM) device serviced this $10m market until recently when the product was permanently withdrawn. In the meantime no product has been available to service this market because no rapid test with a serum or plasma claim had been approved. With immediate effect, through our direct sales force and through a tele-sales team Trinity is in a position to fill this gap and supply the market. Product is available through free phone 1-800-325-3424."
"Rapid HIV Testing in doctor's offices throughout the US is a new market which, while difficult to quantify, will clearly be significant. Trinity is distributing Uni-Gold HIV to this market through a range of distributors." Brendan Farrell, President, added, "Trinity's Uni-Gold Recombigen(TM) HIV has enjoyed significant success in the fight against HIV infection in Africa where it is approved by the World Health Organization and used by the Centers for Disease control in their Voluntary Counselling and Testing Programmes.
With the $15 bn committed by President Bush to combat HIV/AIDS in Africa beginning to flow, Trinity, with its high profile in the African market and its proven production capability, is in an ideal position to assist in making the programme a success."
"We believe that this success can be replicated in the USA where there is an incidence of 40,000 new HIV infections annually. Experience in CDC funded HIV programmes has shown that up to 40% of those tested for HIV using conventional lab based tests will not return for their results. The rapid test allows for on-the-spot results that can increase the diagnosis of infected people. The conversion of these lab based HIV tests to rapid products represents an estimated annual market opportunity of 3 million tests or $30 million."
Trinity Biotech will host a conference call at 11.00 AM Eastern Time on Tuesday, December 30th. The conference call dial-in numbers are as follows: in the USA dial 1-877-780-2271 and in the rest of the world dial 1-973-582-2737. To access the webcast of this call, go to: http://www.viavid.net/detailpage.aspx?sid=000018DD. A replay of the conference call will be available until January 6th, 2004 by dialing: in the USA 1-877-519-4471 and in the rest of the world 1-973-341-3080.
Trinity Biotech develops, acquires manufactures and markets over 500 diagnostic products for the point-of-care and clinical laboratory segments of the diagnostic market. The broad line of test kits are used to detect infectious diseases, sexually transmitted diseases, blood coagulation disorders, and autoimmune diseases. Trinity Biotech sells worldwide in over 80 countries through its own sales force and a network of international distributors and strategic partners. For further information please see the company's website: http://www.trinitybiotech.com.
Forward-looking statements in this release are made pursuant to the "safe harbor" provision of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements involve risks and uncertainties including, but not limited to, the results of research and development efforts, the effect of regulation by the United States Food and Drug Administration and other agencies, the impact of competitive products, product development commercialisation and technological difficulties, and other risks detailed in the Company's periodic reports filed with the Securities and Exchange Commission.
Contacts :
Trinity Biotech plc
IDA Business Park
Southern Cross Road
Bray, Co Wicklow, Ireland
Tel: 353 1 2769800
e-mail: Brendan.Farrell@trinitybiotech.com
or
The Ruth Group
Cynthia Isaac, Ph.D. (Media)
(646) 536-7028
Jill Meleski (Investors)
(646) 536-7032
SOURCE Trinity Biotech plc
Web Site: http://www.trinitybiotech.com
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Always watch for outdated information. This article first appeared in 2003. This material is designed to support, not replace, the relationship that exists between you and your doctor.
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