Technology | June 02, 2010

FDA Clears Home Blood Coagulation Testing System

June 2, 2010 – A portable point-of-care prothrombin time/international normalized ratio (PT/INR) analyzer was released this week. The system detect blood clotting time for patients stabilized on oral anticoagulation medications such as warfarin. The CoaguSense PT/INR monitoring system was recently cleared by the U.S. Food and Drug Administration (FDA) for use by patients in the home by prescription.

The analyzer is also now clinical laboratory improvement amendments (CLIA) waived for use in physician offices. The product consists of a low-cost meter and disposable test strip. Medical professionals can order the system through Abbott Point of Care, which formed an exclusive agreement with CoaguSense to sell and market the CoaguSense PT/INR Monitoring System.

The device is designed for patients requiring the oral anticoagulant warfarin on a long-term basis. For many patients, their blood coagulation levels are checked too infrequently to reduce the risk of bleeding and thrombotic complications. The device offers the ability to test weekly at home.

The routine measurement of prothrombin time is a test performed to control the safe and effective management of oral anticoagulation therapy. Recently, Medicare expanded reimbursement to cover patient self-testing (PST) of prothrombin time at home for the majority of those indications.

The CoaguSense PT/INR Monitoring System is intended for use by properly selected and trained patients or their caregivers on the order of the treating physician. Users should be stabilized on oral anticoagulation medications such as warfarin prior to initiating self-testing with the system. Patients who have recently taken or are currently taking any type of heparin or low molecular weight heparin anticoagulant should not use the system and should consult their doctor. The device is not to be used for screening purposes.

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