DUBLIN, Ireland, November 10 /PRNewswire-FirstCall/ -- Trinity Biotech
plc (NASDAQ: TRIB) today announced that the US Food & Drug Administration
(FDA) has approved a waiver under the Clinical Laboratory Improvements
Amendments of 1988 (CLIA) for the Uni-Gold(TM) Recombigen(R) HIV test.
Trinity Biotech's Uni-Gold(TM) Recombigen(R) HIV test is approved by the
FDA for the detection of antibodies to HIV in human serum, plasma, venous and
finger stick whole blood and is the only Rapid HIV Test to be approved for
use with all four sample types. The product is easy to use, requires one-step
and produces a result within ten minutes. The test is highly accurate being
100% sensitive and 99.7% specific.
The FDA has now approved a waiver for Trinity's Uni-Gold(TM) HIV test
when used with venous and finger stick whole blood. The significance of this
waiver is that the test can be used by almost 200,000 test sites including
physician's offices and clinics in addition to its previously approved
applicability in the hospital environment. CLIA waiver is necessary to
address the public health market segment which is estimated to be three times
the size of the hospital laboratory market. Currently only one other rapid
HIV test competes in this market segment and Trinity's Uni-Gold(TM) product
has the advantages of being twice as fast and more accurate than its
competitor.
"With the receipt of the CLIA waiver for use of Uni-Gold(TM) HIV with
finger stick whole blood, we have now completed the final regulatory hurdle
for our product" said Ronan O'Caoimh, CEO of Trinity Biotech. "Trinity set
out to develop a test which would be approved by the FDA for sale in the
United States utilizing serum, plasma, venous and finger stick whole blood as
samples and this we have achieved. We are proud to have reached this
milestone in Trinity's development and I wish to take this opportunity to
thank all of the Trinity staff who helped to make this possible.
During 2004 our 90 strong sales & marketing team in the United States
launched Uni-Gold(TM) HIV in the hospital market and with the finger stick
approval and CLIA waiver, this group will now also turn its focus on to the
significantly larger public health and physician's office market segments. We
are excited at the prospect of what this means for Trinity Biotech's future
growth and know that our successful experience of marketing the product in
sub-Saharan Africa can be applied to the U.S. market".
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 salesforce and a network of international
distributors and strategic partners. For further information please see the
Company's website: 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.
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