CE Mark ApprovalSiemens has received CE mark approval for the Xprecia Stride Coagulation Analyzer, the first point-of-care (POC) coagulation analyzer developed in partnership with Universal Biosensors.

According to the news report announcing this, CE mark approval for this product indicates that it is fully compliant with all relevant EU legislation which allows it to be sold within 31 countries operating in the European Economic Area.

Xprecia Stride is an advanced PT-INR testing system for monitoring the application of the anti-coagulant therapy Warfarin. Compact, ergonomic and user-friendly, it is designed to deliver results within minutes for point of care. Siemens had showcased the Xprecia Stride Coagulation Analyzer at the IFCC EuromedLab 2013 and IFCC WorldLab Istanbul 2014.

Universal Biosensors had received two commercial orders from Siemens for the production and supply of PT-INR (prothrombin time) test strips. Universal Biosensors will exclusively manufacture the strips for Siemens at its existing plant in Rowville, Victoria, Australia.

Siemens offers a wide range of hematology analyzers and immunoassay, molecular, urinalysis, and blood gas testing systems, in conjunction with automation, informatics and services, serving the needs of laboratories of any size and providing laboratory-quality, time-critical results to clinicians.

A medical diagnostics company focused on the research, development and manufacture of POC diagnostic platforms, Universal Biosensors (ASX: UBI) has a strong position in the rapid growth POC healthcare sector.

About 10 million patients worldwide take Warfarin, an anticoagulant which reduces the formation of blood clots. The drug is prescribed to prevent heart attacks, strokes, and blood clots in veins and arteries. Patients on Warfarin require frequent PT-INR time tests to measure their blood-clotting time. Physicians make adjustments to patient doses for diet and lifestyle changes based on the results of the test.

It is reported that the worldwide point-of-care coagulation testing market was valued at around US1.0 billion in 2014 and is predicted to grow by 9% per annum to US1.4 billion by 2018.