Cardiovascular disease (CVD) is the leading cause of mortality in the western world, accounting for over 40% of total deaths each year. Measurement of plasma homocysteine using Axis-Shield technology may be an important parameter in the detection of disease risk. Additionally we provide methods to detect D-Dimer, a marker of clot formation, together with a number of methods to measure efficacy of anticoagulant treatment.

Up to 70% of individuals who develop heart attacks have normal levels of cholesterol, a test widely recognised as an indicator of coronary artery disease, so it is clear other factors besides plasma lipids are involved in many forms of this disease.

The medical community recognises that there is a need for better indicators of CVD risk. The cost to monitor and treat patients suffering from CVD, including heart attacks and other cardiac events such as strokes is enormous. According to the American Heart Association (AHA), the total financial cost of CVD and strokes in the US alone during 2001 was estimated at over $298 billion.

The causes of CVD are multifactorial and therefore the Company is working on the development of a number of different products to assess CVD risk. Axis-Shield believes that these new markers will ultimately provide medical practitioners with the information they need to prescribe the most efficacious and cost effective therapies, the result being a healthier patient leading a more comfortable lifestyle and more efficient management of a chronic and potentially fatal disease. In the future we believe that early diagnosis and remedial action may be able to reduce the overall burden of cardiovascular disease.

Most of our current revenue in this product area is derived from sales of tests to measure homocysteine, which has additional utility in identification of increased risk of neurodegenerative disease. Main revenues continue to come from our OEM arrangements for our immunoassay products with companies such as Abbott Laboratories, Siemens Diagnostics platforms and IL. Axis-Shield has also acquired rights to the clinical chemistry homocysteine detection technology of Catch Inc., and this is now available for a number of proprietary analysers.

Cardiovascular disease is endemic in the western world, costing millions of lives every single year. Axis-Shield Point of Care are developing tests that can be used as an indication for the risk of developing cardiovascular disease, or to monitor drugs used for anticoagulation therapy.

Acute blood clots
Elevated levels of fibrin degradation products (D-dimer) are indicative of the presence of a significant blood clot. Blood clots form when long strands of fibrin attach to each other to form a clot. Meanwhile, the cell walls initiate a mechanism that can dissolve the coagulated blood, and the marker D-dimer is one of the products released during this process. Formation of blood clots may be induced by a variety of causes including deep venous thrombosis or pulmonary embolism. Axis-Shield markets tests for D-Dimer under the AxSYM xtra programme and on the NycoCard point-of-care system.

Anticoagulation therapy
Several conditions such as myocardial infarction, venous thrombosis, pulmonary embolism, hip surgery, valvular heart disease etc. initiate the use of anticoagulation therapy. To ensure correct dosage of the preferred drug, Thrombotest or Nycotest PT can be used to monitor treatment with anticoagulants.

We are currently developing an Afinion assay for high sensitivity C-Reactive Protein (hsCRP) as a marker of inflammation associated with CVD and atherosclerosis