26 Jun 2008 07:00
Embargoed: 0700hrs 26 June 2008
Akers Biosciences, Inc.
("ABI" or the "Company")
ABI Signs Distribution Agreement with Trinity Biotech for Heparin Allergy Test
Akers Biosciences, Inc (AIM:AKR), a leading designer and manufacturer of rapid diagnostic screening and testing products, is pleased to appoint Trinity Biotech plc (NASDAQ: TRIB) ("Trinity") as a distributor of ABI's unique PIFA Heparin/Platelet Factor-4 Rapid Assay (HPF4) in the USA and German markets.
Trinity Biotech is a specialist in the marketing and distribution of clinical diagnostic products. Founded in 1992, and listed on the NASDAQ, Trinity is now active in over 75 countries. This distribution agreement is additional to Akers' existing US distribution through Cardinal Health, who continue to market the HPF4 test.
Certain segments of the medical community have, for some time, been aware of the potential side-effects associated with the use of heparin, the most commonly used anticoagulant in the world. However, the past six months have seen the situation thrust into the public eye following a series of deaths in the USA and Europe linked to the drug, which is used during and after a variety of surgeries including open heart, bypass, and orthopedic procedures, and also kidney dialysis. ABI has the only rapid test in the world for Heparin-Induced Thrombocytopenia ("HIT"), otherwise explained as a "heparin allergy," a serious side-effect of heparin which can rapidly progress in minutes or hours, and can result in death or dismemberment. The compelling medical necessity for a rapid procedure to diagnose those at risk of, or suffering from, HIT has highlighted the requirement for an upscaling in ABI's distribution of the test, and hence today's distribution deal with Trinity.
Thomas A. Nicolette, Chief Executive, commented,
"This is the first major additional distribution deal for HPF4 and serves to highlight the increasing worldwide medical importance of the test. Trinity is an impressive business, which can effectively penetrate new markets with our product. We are pleased to be widening the distribution through Trinity of our HPF4 product, which we believe must become a standard of care in anticoagulant therapy across the globe."
Enquiries:
Thomas A. Nicolette
President and CEO
Tel. +1 856 848 8698
Ben Simons or Eleanor Williamson
M: Communications
Tel. +44 (0)20 7153 1540
Alasdair Younie
Arbuthnot Securities Limited
Tel. +44 (0)20 7012 2139
About PIFA® Heparin Platelet Factor 4 Rapid Assay (HPF4)
The Company's patent protected, rapid HPF4 test is sold under the Company's brand "PIFA Heparin/PF-4 Rapid Assay." It is the first rapid test for HPF4 antibodies. The market response clearly indicates a significant clinical need for the product, and several studies have been presented at scientific meetings indicating that the Company's test may be more accurate than any competitor on the market.
Heparin is the most widely used intravenous anticoagulant, and is commonly used for the prophylaxis and treatment of thromboembolic disease, as well as numerous other applications including certain types of lung and heart disorders, and during or after a variety of surgeries including open heart, bypass, dialysis and orthopedic procedures. Patients with recent exposure to heparin are at a much greater risk for developing Heparin-Induced Thrombocytopenia ("HIT"), than are those not having previously been given the drug. The Company's 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.
The Company and its partners have initially promoted the use of the test 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 Company's product has significant advantages both in terms of cost and time to result. The Company's test takes minutes to perform, while the current laboratory tests take hours to perform on complex instrumentation. HIT can rapidly progress in minutes or hours, and can result in death or dismemberment. The Company's product is the only test available on the market that can provide real-time information that can be useful in formulating a clinical diagnosis. More than 12 million doses of heparin are administered annually in the United States alone and approximately 3.5 million tests are performed each year in the using current laboratory tests to confirm a potential "heparin allergy" or HIT, primarily in cardiology and emergency medicine patients. The Company's HPF4 rapid assay is significantly faster, less expensive and may be more accurate than these current laboratory based tests, thereby offering compelling medical and economical reasons for replacing them.
About Trinity Biotech plc
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.