SOURCE: Trinity Biotech

June 26, 2008 08:00 ET

Trinity Biotech plc Signs Agreement With Akers Biosciences for Distribution of ABI Heparin Allergy Test

DUBLIN, IRELAND--(Marketwire - June 26, 2008) - Trinity Biotech plc (NASDAQ: TRIB) is pleased to announce that it has been appointed by Akers Biosciences, Inc (LSE: AKR) ('ABI'), a leading designer and manufacturer of rapid diagnostic screening and testing products, as a distributor of its unique PIFA Heparin/Platelet Factor-4 Rapid Assay (HPF4) in the USA and German markets.

Heparin is the most widely used intravenous anticoagulant, and is commonly used for the prophylaxis and treatment of thromboembolic disease. It also has numerous other applications such as the treatment of certain types of lung and heart disorders and after a variety of surgeries including open heart, bypass, orthopedic procedures and kidney dialysis. Certain segments of the medical community have, for some time, been aware of the potential side-effects associated with the use of heparin. However, the past six months have seen the situation thrust into the public eye following a series of deaths linked to the drug in the USA and Europe.

In 2006, over 3.5 million tests were performed in the US using current laboratory tests to confirm a potential "heparin allergy" or Heparin-Induced Thrombocytopenia ("HIT"), primarily in cardiology and emergency medicine patients. However, more recently, with the greater market focus and patient awareness on the potential side affects of heparin the level of testing has been increasing.

About PIFA® Heparin Platelet Factor 4 Rapid Assay (HPF4)

The test detects the presence of Heparin/PF-4 antibody, which is associated with patients at risk for HIT, and is rapidly becoming a standard of care in hematology and cardiology. It is the first rapid test for HPF4 antibodies and several studies have been presented at scientific meetings indicating that this test may be more accurate than any other product on the market.

The HPF4 test is currently being sold into the US clinical laboratory market under the name "PIFA Heparin/PF-4 Rapid Assay." The test is being promoted as a replacement for current laboratory tests used in the detection of a heparin "allergy" or other serious thrombolytic reaction resulting from heparin treatment.

The ABI assay is the first rapid test in the world for HIT and the only test available on the market that can provide real-time information that can be useful in formulating a clinical diagnosis. This has significant advantages both in terms of cost and time to result compared to current laboratory tests which take hours to perform and require complex instrumentation. This is a key factor in acute patient management as HIT can rapidly progress in minutes or hours, and can result in death or dismemberment.

In selling this product, Trinity Biotech will target coagulation and haematology laboratories and clinical settings, such as Emergency Room, Surgical and Dialysis units in the hospital markets where Trinity already sells its existing products.

Commenting on the agreement, Brendan Farrell, CEO of Trinity Biotech, said, "The addition of the ABI HPF4 product is a natural fit to our well established coagulation and point-of-care portfolio. We see great synergies for our sales and marketing organisation which is well placed to drive the growth of this important life saving product in the specialist hospital and clinical laboratory arena."

Thomas A. Nicolette, Chief Executive of ABI, commented, "This is a major additional distribution deal for HPF4 and serves to highlight the increasing worldwide medical importance of the test. Trinity Biotech is an impressive business, which is ideally positioned to penetrate new markets with our product. We are pleased to be widening the distribution through Trinity Biotech of our HPF4 product, which we believe must become a standard of care in anticoagulant therapy across the globe."

About Akers Biosciences.

Since 1989, ABI's team of Research and Development specialists has taken an aggressive approach to advancing the science of diagnostics while responding to major shifts in healthcare. Instead of waiting hours or even days for test results, its innovative, unit-use devices can be performed in minutes, to facilitate time-sensitive therapeutic decisions.

ABI is headquartered in North America in Thorofare, New Jersey USA, with a European office located in London, England. For additional information, please see www.akersbiosciences.com

About Trinity Biotech

Trinity Biotech develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market. The products are used to detect infectious diseases and blood coagulation disorders, and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States, Germany, France and the U.K. and through a network of international distributors and strategic partners in over 75 countries worldwide. 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 commercialization and technological difficulties, and other risks detailed in the Company's periodic reports filed with the Securities and Exchange Commission.

Contact Information

  • Contact:
    Trinity Biotech plc
    Niamh Long
    Investor Relations Officer
    (353)-1-2769800
    Email Contact

    Joe Diaz, Joe Dorame, Robert Blum
    Lytham Partners, LLC
    (602) 889-9700