News: Universal Biosensors, Siemens blood coagulation analyser receives CE Mark

Universal Biosensors (ASX:UBI) is taking step forward with Siemens Healthcare Diagnostics receiving CE Mark approval for the jointly developed Xprecia Stride™ Coagulation Analyzer, the first point-of-care coagulation analyser.

This indicates the product is fully compliant with all relevant EU legislation and allows it to be sold within 31 countries operating in the European Economic Area.

The CE marking follows receipt of two commercial orders from Siemens for the production and supply of PT-INR (prothrombin time) test strips by Universal Biosensors.

Xprecia Stride™ is PT-INR testing system used to monitor the application of the anti-coagulant therapy, Warfarin.

Universal Biosensors will exclusively manufacture PT-INR strips for Siemens at its existing plant in Rowville, Victoria.

It is estimated about 10 million patients globally are taking Warfarin. Patients are prescribed the drug for a variety of reasons, including the treatment of blood clots in the veins or certain heart conditions which increase the likelihood of a potentially life-threatening clot forming.

Patients on Warfarin require frequent testing of the clotting tendency of their blood. PT-INR testing allows physicians to adjust patient doses for diet and lifestyle changes.

The worldwide point-of-care coagulation testing market was estimated at around US$1.0 billion in 2014 and is forecast to grow by 9% per annum to US$1.4 billion by 2018.