Thursday January 17, 8:08 am Eastern Time
Press Release
SOURCE: Trinity Biotech plc
Trinity Biotech Receives FDA Clearance for Uni-Gold(TM) Strep A Rapid Test
DUBLIN, Ireland, Jan. 17 /PRNewswire-FirstCall/ -- Trinity Biotech plc (Nasdaq: TRIB - news) today announced that it has received U.S. Food and Drug Administration (FDA) marketing clearance for its Uni-Gold(TM) Strep A One-Step-Test. The Company currently sells the Uni-Gold Strep A test outside the U.S., and will now address the $43m U.S. market. The worldwide market for Strep A testing is calculated at US$80m.
Uni-Gold(TM) Strep A is intended as an aid to the diagnosis of Group A Streptococcus. This bacterium is commonly referred to as ``Strep A'' and is responsible for infections of the throat known as Streptococcal Pharyngitis. Left untreated, these infections can lead to life-threatening diseases including rheumatic fever and pneumonia. In the U.S. alone, it is estimated that there are 25-35 million physician visits each year for suspected Group A Streptococcal infections.
Streptococcal Pharyngitis can be treated effectively with antibiotics, however clinical findings alone do not adequately distinguish Strep and non-Strep Pharyngitis. Antibiotic resistance is a global problem and it is recommended that antibiotics should not be given to a child with Pharyngitis without testing for Group A Streptococcus. Uni-Gold(TM) Strep A provides a result in five minutes thus allowing for prompt diagnosis and appropriate treatment.
Ronan O'Caoimh, Trinity Biotech's C.E.O., commented, ``We are very pleased to be able to expand our Uni-Gold(TM) range of rapid diagnostic tests with our latest product Uni-Gold(TM) Strep A. Acute Pharyngitis is one of the most frequent illnesses for which pediatricians and other primary care physicians are consulted. Uni-Gold(TM) Strep A will be a significant aid to the correct diagnosis of this condition and will facilitate the administration of antibiotic therapy when appropriate. Our product has a unique design and demonstrates distinct advantages over competitive products currently on the market. We will market the test in the U.S.A. through our own sales force and through national and regional distributors.''
Uni-Gold(TM) Strep A is the latest addition to the Trinity Biotech family of infectious disease rapid tests. These products include Uni-Gold(TM) HIV, Uni-Gold(TM) Hepatitis B, Uni-Gold(TM) H.Pylori and Uni-Gold(TM) Malaria.
Trinity Biotech develops, manufactures and markets over 200 diagnostic products for the point-of-care, self-testing and clinical laboratory segments of the diagnostic market. Trinity Biotech sells worldwide in over 80 countries, through its own sales force and through a network of international distributors and strategic partners. For further information please see our website: 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 commercialization and technological difficulties, and other risks detailed in the Company's periodic reports filed with the Securities and Exchange Commission.
Contact: Trinity Biotech plc
IDA Business Park
Southern Cross Road
Bray, Co Wicklow, Ireland
Maurice Hickey
Tel: 353 1 2769800
e-mail: mhickey@trinitybiotech.ie
Or: Noonan Russo Communications Inc.
Amy Garay
Tel: 212 696 4455
e-mail: a.garay@noonanrusso.com
SOURCE: Trinity Biotech plc
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