Randox TxB Cardio Assay Gains CE Approval

Global diagnostics company Randox Laboratories has secured CE marking for their TxB Cardio Assay. TxB Cardio is used to measure the effectiveness of aspirin (ASA), a drug which is used therapeutically around the world for its blood thinning properties. Clinical studies have shown that up to 25-30% of all patients who regularly take low doses of the drug are resistant to its full affects, meaning that these patients are at a considerably increased risk of a future cardiovascular event.

The primary action of aspirin is to inhibit the production of thromboxane in the blood, a chemical which helps to cause blood clotting. However, methods of directly measuring the level of thromboxane in blood are unreliable, and so not widely used. TxB Cardio measures a direct urinary metabolite of thromboxane, 11dhTxB₂, therefore providing a reliable and stable measure of a patients response to their daily aspirin therapy.

TxB Cardio is the latest generation assay for measuring 11dhTxB₂, and means that it can now be tested by hospitals and clinics via their routine laboratory instruments, without the need for dedicated and expensive additional equipment. Randox also offers TxB quality controls and calibrators, delivering a complete testing package.

Speaking after the approval announcement, Randox Managing Director Dr Peter FitzGerald said,

“We are delighted to bring this, the first automated assay of its kind on to the global market. 11dhTxB₂ has been clinically validated as an independent predictor of myocardial infarction (MI) and cardiovascular death in patients suffering from decreased aspirin sensitivity. The 25-30% of patients thought to be aspirin resistant have a 2 fold risk of MI and are 3.5 times as likely to die as a result of a cardiovascular incident, than those who respond fully to their aspirin therapy. This test therefore has the potential to have a significant impact on identifying and prescribing these patients with alternative and more personalised treatment.”