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March 5, 2013
07:23 EDTTRIBTrinity Biotech reports Q4 EPS 21c, consensus 21c
Reports Q4 revenue $20.8M, consensus $21.84M. The company is making significant progress in the development of its new cardiac point of care tests. With regard to Troponin I, the company is currently focusing on completing development of the test with a view to meeting the new FDA guidelines for Troponin I. The company is also preparing for the forthcoming CE marking trials which will take place at multiple sites in Europe, commencing in Q2. CE marking remains on target for Q4 after which sales in the European market will commence. FDA trials are due to commence in Q3 with submission to the FDA scheduled for 1Q14.
News For TRIB From The Last 14 Days
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December 16, 2014
11:28 EDTTRIBTrinity Biotech announces CLIA waiver of rapid syphilis test
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09:58 EDTTRIBTrinity Biotech's CLIA waiver an unexpected positive, says Craig-Hallum
The FDA granted the first-ever CLIA waiver for a point of care Syphilis test. Craig-Hallum said Trinity has the exclusive right to sell in the U.S. market, which could add $3M-$5M in 2015 revenues, and $10M-$15M longer term. Shares are Buy rated.
December 15, 2014
12:17 EDTTRIBSyphilis test distributed by Trinity gets CLIA waiver from FDA
The FDA announced that it granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis, which will allow the Syphilis Health Check test to be used in a greater variety of health care settings. The FDA's waiver is related to the Clinical Laboratory Improvement Amendments, federal standards that apply to clinical laboratory testing on humans, with certain exceptions. Because the FDA granted a waiver under CLIA, the Syphilis Health Check test can be distributed to a variety of nontraditional laboratory sites, including physicians' offices and emergency rooms. The waiver also allows untrained health care workers to perform the tests on patients. The Syphilis Health Check test is manufactured by VEDA LAB of France for Diagnostics Direct. It is also distributed by Trinity Biotech (TRIB).

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