Coagulation Testing

Following on from its successful validation in blood glucose testing, Universal Biosensors (UBI) has adapted its electrochemical cell to measure Prothrombin Time (PT/INR), a test used to monitor the effect of the anticoagulant therapy warfarin.

UBI has developed the Xprecia Stride™ Coagulation Analyzer for Siemens Healthcare Diagnostics, to provide a quick, convenient and accurate method for medical practitioners to conduct the test.

The test is used to maintain patients on a safe and effective dose of warfarin. If patients are taking too much warfarin they are at risk of serious bleeding events and if too little they are at risk of thrombosis. The prothrombin time test allows physicians to adjust patient doses for diet and lifestyle changes. It is estimated that over 10 million people are taking warfarin and more than 200 million PT-INR tests are conducted each year worldwide.

The point-of-care coagulation monitoring market is estimated to be worth approximately US$1 billion globally with point-of-care PT-INR testing making up over 65% of this market.  

UBI has signed a long term supply and manufacturing agreement with Siemens to exclusively manufacture three test strips for the point-of-care coagulation market.  The first product, a PT/INR test, was launched in December 2014. Siemens will register, market and sell these point-of-care coagulation tests globally. 

Point-of-care coagulation testing takes place in three broad settings:

  • Hospitals
  • Alternative Site Testing, including doctors offices, clinics, pharmacies, etc
  • Patient self-testing in the home

The coagulation testing products being developed and manufactured for Siemens will be targeted at the first two market segments above,

In addition, UBI is developing its own system for use in decentralised settings including the patient self-test market. Incorporating specific features that are suited to these setting, UBI aims to distribute this system via specialist distributors in key international markets.