Xprecia Prime™

The Universal Biosensors Xprecia Prime™ is an innovative portable coagulation monitoring device designed for fast and reliable prothrombin time (PT) and International Normalised Ratio (INR) testing, particularly for patients receiving vitamin K antagonist oral anticoagulation therapy, including widely used medications such as Warfarin and Coumadin. Building on the successful development of the Xprecia Stride™ Coagulation Analyser device, D+I focused on the mechanical design and integration of electronics architectures of the next-generation Prime™ device, working alongside Universal Biosensors' internal software and electronics engineering teams. The analyser boasts a small hand-held form factor, and user-friendly interface, capable of providing PT/INR results in under a minute, closely resembling laboratory analysis.

Globally, approximately 10 million patients are taking warfarin, and over 200 million PT/INR tests are conducted annually to monitor the safe and effective dosage of anticoagulants. Providing instant results in various healthcare settings, including point of care (POC), primary care, urgent care, and hospitals, can assist in preventing adverse treatment outcomes. The prothrombin time (PT) test allows physicians to appropriately adjust the patient’s dose of the drug to compensate for any diet and lifestyle changes. Xprecia Prime™ 4U has received the approval required for sale directly to patients for self-testing in Europe. The approval is in the form of the EU Technical Documentation Assessment Certificate (IVDR) issued in accordance with Regulation (EU) 2017/746 on in vitro diagnostic medical devices (Class C) for Patient Self-Testing/near patient testing. This approval has been issued by TÜV SÜD Product Service GmbH. This approval empowers patients to perform PT/INR testing at home, aligning with the growing European market for Patient Self-Testing, where the preference for approved self-testing solutions is on the rise.

To learn more, visit www.universalbiosensors.com