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February 28, 2012

EC Grants CE Mark for Trinity’s Point-of-Care Test for Giardiasis

  • Trinity Biotech received a European CE Mark for its point-of-care (POC) Uni-Gold™ Giardia Test, and has filed for FDA approval of the Giardiasis diagnostic. Uni-Gold Giardia is a 15-minute lateral flow immunoassay to detect presence of the causative Giardia lamblia antigen in fresh and preserved human stool samples.

    Trinity announced back in 2010 its plans to develop a range of POC tests at its San Diego facility. Uni-Gold Giardia is the first in the resulting line of POC enteric diagnostics, including tests for Cryoptosporidium and C. difficile, which it aims to have CE marked by mid-2012 and approved in the U.S. during the latter half of 2013. These tests will quickly be joined by assays for syphilis, strep pneumonia, and HSV, states Trinity Biotech CEO, Ronan O’Caoimh.

    Trinity specializes in the development, manufacture, and marketing of clinical laboratory and POC diagnostic test kits, for the detection of infectious and sexually transmitted diseases, autoimmune and hemoglobin disorders, and the detection, monitoring, and control of diabetes. The firm’s existing POC business generated revenues of nearly $4 billion in the third quarter of 2011, down 6% due primarily to lower HIV sales in Africa because of timing factors, which it expects to be offset by correspondingly increased Q4 2011 revenues. Trinity’s clinical laboratory operation recorded revenues of $15.9 billion in Q3 2011, up 9% overall, including a 13% rise in its core diabetes/infectious diseases revenues. 

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