Blood coagulation testing system approved for the European market

9 December 2014

Universal Biosensors, Inc. (ASX: UBI) is pleased to announce that Siemens Healthcare Diagnostics Inc. (“Siemens”) has received CE Mark approval for the Xprecia Stride™ Coagulation Analyzer, the first point-of-care coagulation analyzer developed in collaboration with Universal Biosensors.

The Xprecia Stride™ Coagulation Analyzer is a prothrombin time (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 the Company’s existing plant in Rowville, Victoria.

The CE marking follows the receipt of two commercial orders from Siemens for the production and supply of PT-INR test strips by Universal Biosensors, and is the final step prior to product launch in Europe.

The CE marking is mandatory for any company prior to selling its product within the 31 countries operating in the European Economic Area. The CE marking indicates a product is fully compliant with all relevant EU legislation and can move freely within the European Economic Area.

It is estimated about ten 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.

According to recent research, 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 2018.1 The coagulation testing market is dominated by PT-INR testing, which represents about 65% of this market.

Universal Biosensors CEO Paul Wright said: “Receipt of the CE marking is an important step prior to the market launch of this exciting new coagulation testing product developed in partnership with Siemens. We are looking forward to the launch of this new device and continue to work with Siemens to bring powerful and innovative systems to point-of-care testing.”

Mr Paul Wright: 03 9213 9000
1 Espicom, “The Cardiology Point-of-Care Diagnostics Market to 2018”, July 2014

About Universal Biosensors
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Universal Biosensors is a specialist medical diagnostics company, founded in 2001, that is focused on the development, manufacture and commercialisation of a range of in vitro diagnostic tests for point-of-care use. These tests capitalise on a technology platform which uses a novel electrochemical cell that can be adapted for multiple analytes and provide for enhanced measurements in whole blood.

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