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Irish firm gets OK for HIV test

February 16, 2011

By Staff Reporter

The test is simple to use, requiring only one step, and takes just 10 minutes, whereas with conventional laboratory tests, results may not be available for hours or even days.
In recent years, the Dublin-based public company (NASDAQ: TRIB) has emerged as a world leader in the field of diagnostic medical devices. It now ships 120 of its market-leading products through distributors in 80 countries from its manufacturing facilities in Dublin, New York and California.
The company specializes in the development, manufacture and marketing of diagnostic products such as Uni-Gold Recombigen, the only such test that can screen serum, plasma and whole blood.
The product is already used extensively in Africa.
Uni-Gold Recombigen HIV was approved by the FDA on the basis of clinical trial results on more than 9,000 patients, where the product demonstrated a test sensitivity of 100 percent.
Trinity had increased its sales force here in anticipation of the approval by the FDA.
The company was formed in 1992 and attained its first full year of profit in 1997. Led by it chairman and chief executive officer, Ronan O’Ciamh, and its president, Brendan Farrell, Trinity Biotech expanded in the 1990s through a combination of internal and acquisition-led growth.
In both in-house research and development and acquisitions, the company has assembled an impressive product portfolio, achieving excellence in developing, manufacturing and marketing quality products that meet market demands.
Trinity’s list of acquisitions is impressive. In 1994 the company took over the Disease Detection International of Irvine, Calif.; in 1997, it acquired Clark Laboratories, located in Jamestown, N.Y., and also Centocor, based in the UK; in 1998, Trinity took over the hormone and drugs-of-abuse product lines from Diatech, Boston; in 1998, it also acquired Macra Lp(a) product from Strategic Diagnostics Inc. Later that year, it got the HIV product line from Cambridge Diagnostics and also the MicroTrak product line from Dade Behring.
Trinity’s consolidating acquisitions streak continued into the new millennium. In 2000, it acquired MarDx Diagnostics, Inc., and it also picked up the assets and goodwill of Bartels Inc. In 2001, it acquired Biopool hemostasis business and in 2002 it completed the acquisition of Hemostasis Division of Sigma Diagnostics and the Specialty Clinical Chemistry business from Sigma Diagnostics.
Commenting on last week’s decision, CEO O’Caoimh said: “We are delighted to receive FDA approval of our Uni-Gold HIV test. We are now able to enter all market segments of significance in the United States. Uni-Gold HIV has become the gold standard in the fight against Aids in Africa.”
Approximately 800,000 needle injuries occur in U.S. hospitals each year requiring an immediate serum/plasma HIV test. In addition approximately 200,000 at-risk pregnant women require a rapid HIV test annually. Until now no product was available to service this market because no rapid test with a serum or plasma claim had been FDA approved. Trinity Biotech is now in a position to fill this gap and supply the market.
Farrell, the company president, said: “Trinity’s Uni-Gold Recombigen HIV test 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 counseling and testing programs. We believe that this success can be replicated in the U.S.A. where there is an incidence of 40,000 new HIV infections annually.”
Experience in U.S. HIV programs has shown that up to 40 percent 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.

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