Universal Biosensors obtains European approval for blood coagulation system
THE ROADHOUSE PHARMACY: Universal Biosensors (ASX: UBI) announced that Siemens Healthcare Diagnostics has received CE Mark approval for the Xprecia Stride™ Coagulation Analyzer, a first point-of-care coagulation analyser 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.
Universal Biosensors said 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 company explained 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.
“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,” Universal Biosensors CEO Paul Wright said in the company’s announcement to the Australian Securities Exchange.
“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.”
Email: info@universalbiosensors.com
Website: www.universalbiosensors.com