Profile: Trinity Biotech PLC (TRIB.O)

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Trinity Biotech plc (Trinity Biotech), incorporated on January 22, 1992, develops, acquires, manufactures and markets medical diagnostic products for the clinical laboratory and point-of-care segments of the diagnostic market. These products are used to detect autoimmune, infectious and sexually transmitted diseases, diabetes and disorders of the liver and intestine. Trinity Biotech also is a provider of raw materials to the life sciences and research industries globally. Trinity Biotech markets its portfolio of almost 850 products to customers in approximately 100 countries around the world through its own sales force and a network of international distributors and strategic partners. The primary market for Trinity Biotech's diagnostic products is the Americas (which consists principally of North America and South America). Trinity Biotech also sells raw materials to the life sciences industry and research institutes globally through its wholly owned subsidiary, Benen Trading Ltd., trading as Fitzgerald Industries. Trinity Biotech sells its products through its direct sales organizations in the United States, Brazil and the United Kingdom, and through a network of principal distributors and Non-Governmental bodies into approximately 100 countries globally. The Company's products are classified as point-of-care, emergency medicine, clinical laboratory and blood bank screening.

Point-of-Care

Point-of-care refers to diagnostic tests, which are carried out in the presence of the patient. The Company offers point-of-care under Uni-Gold and Recombigen names. Trinity Biotech also offers Uni-Gold S. pneumoniae, Uni-Gold Legionella, Uni-Gold C. difficile and Uni-Gold Syphilis.

Emergency Medicine

Emergency medicine diagnostics refers to the Company's acute care testing, which are critical time-sensitive diagnostic tests performed in emergency rooms, STAT labs, pre/post-operative units, physician office labs and the central laboratory. Troponin I is a recognized marker for detecting acute myocardial infarctions. The Company's emergency medicine diagnostics are in clinical development-stage. The Company also offers a Brain Natriuretic Peptide (BNP) test. BNP is a biomarker utilized in aiding the diagnosis of and determining the clinical severity of acute and chronic heart failure. In addition, BNP can be useful in a wide range of clinical applications, including risk stratification and monitoring of patients with heart failure and heart attacks.

The Company is focused on expanding its offering on the Meritas POC Analyser. The focus of the Company's development efforts is to continue to expand the test menu to include assays for deep vein thrombosis and pulmonary embolism (D-dimer), and other valuable areas of need in emergency medicine. Trinity Biotech offers the Meritas Troponin and BNP products for sale in Europe and other selected markets through its specialist Cardiology Distributor network.

Clinical Laboratory

Trinity Biotech supplies the clinical laboratory segment of the in-vitro diagnostic market with a range of diagnostic tests and instrumentation which detect infectious diseases, Hemoglobin and autoimmune diseases. Trinity Biotech also supplies clinical laboratory market with reagent products and other products through its clinical chemistry business. The Company sells clinical laboratory products under Bartels, MarDx, MarBlot, Premier, Ultra2, ImmuBlot, ImmuGlo, ImmuLisa, OTOblot and EZ.

Trinity Biotech manufactures products for applications in infectious diseases. The products are used with patient samples and the results generated help physicians to guide diagnosis for a range of infectious diseases, which include Lyme disease; sexually transmitted diseases, including syphilis, chlamydia and herpes simplex virus; respiratory infections, including legionella and influenza; Epstein Barr virus, and other viral pathogens, including measles, mumps, rubella and varicella. Trinity Biotech develops, manufactures and distributes products in immunofluorescence (IFA), enzyme-linked immunosorbent (ELISA), western blot (WB) and cytotoxicity assay formats for diagnosis of infectious diseases. The Company's automation offering includes ELISA and western blot processors.

Primus Corporation, a Trinity Biotech company, focuses on products for in-vitro diagnostic testing for hemoglobin A1c used in the monitoring and diagnosis of diabetes and Hb Variants for the detection of haemoglobinapothies. Primus manufactures a range of instruments that use patented boronate affinity technology for point-of-care platforms and for high-performance liquid chromatography, or HPLC, platforms, as follows: Haemoglobin A1c, or HbA1c, is a measure of a patient's average blood sugar control over the last two to three months. HbA1c is a biomarker available for the diagnosis of diabetes and is an indicator of a diabetics glycemic control; Haemoglobin Variant, a Primus Ultra instrument for detection of hemoglobin variants which is important for screening populations for genetic abnormalities that can lead to conditions, such as sickle cell anemia and thalassemia, and Neonatal Haemoglobin, the GeneSys system for the detection of Haemoglobin variants in neonatal patients. Trinity is developing an ion exchange version of the Premier Hb9210 which is capable of detecting both HbA1c and hemoglobin variants.

Trinity Biotech also operates through Immco Diagnostics, an autoimmunity company known for assay development and impactful contributions to autoimmune disease diagnostic research. Immco develops, manufactures and distributes products in the following formats for diagnosis of autoimmune diseases: IFA, ELISA, WB and line immunoassay, or LIA. The Immco products are sold through Trinity Biotech's sales and marketing organization to clinical and reference laboratories directly in the U.S. and via distributors in other countries. The specialty clinical chemistry business of Trinity Biotech includes reagent products, such as ACE, bile acids, lactate, oxalate and glucose-6-phosphate dehydrogenase (or G6PDH).

Blood Bank Screening

Trinity Biotech's blood bank screening business unit manufactures a number of products to screen donated blood for transfusion-transmissible infections. The Company offers blood bank screening products under Captia and MicroTrak names. Trinity Biotech manufactures immunoassays for the detection of syphilis, CMV and malaria. The blood bank products are sold through direct and distributor sales channels and are manufactured under original equipment manufacturer agreements for other third party diagnostic companies. The business has market share in Europe.

The Company competes with Abbott Diagnostics, Alere Inc., Arkray, Bio-Rad, Diasorin Inc., Euroimmun, Johnson & Johnson, OraSure Technologies Inc., Phadia, Roche Diagnostics, Siemens, Thermo Fisher, Tosoh and Werfen.

Company Address

Trinity Biotech PLC

IDA Business Park
BRAY     18
P: +3531.2769800
F: +3531.2769888

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