Located in Fremont, CA, CoaguSense has obtained FDA approval of its portable PT/INR (Prothrombin Time/International Normalized Ratio) analyzer for patient self-testing (PST) by prescription. Consisting of a low-cost meter and disposable test strip, the device detects blood clotting time for patients stabilized on oral anti-coagulants warfarin or Coumadin.
The device incorporates a novel direct micromechanical clot detection technology. This propriety technology emulates the World Health Organization (WHO) gold standard tilt-tube method while requiring only a very small blood sample. Direct clot detection technology provides clinicians with the system reliability they demand and patients with comfort of knowing that proper home testing can provide dependable results like a laboratory.
Routine measurement of prothrombin time is a test performed to control the safe and effective management of oral anticoagulation therapy to treat conditions such as congestive heart failure (CHF), atrial fibrillation, prosthetic heart valve, myocardial infarction (MI), joint replacement, deep vein thrombosis (DVT) pulmonary embolism, thrombotic stroke, coronary artery disease (CAD), venous thromboembolism and cancer. Medicare has recently expanded reimbursement to cover patient self-testing (PST) of prothrombin time at home for the majority of these indications.