27/02/2007: Next-generation system FDA-cleared for physician’s office use and Patient Self-Testing

Roche Diagnostics announced today that it is introducing in the USA the latest advancement in point-of-care (POC) anticoagulation monitoring, the CoaguChek® XS System, for physician’s office use and self-testing by patients on warfarin therapy.

Physicians have been using CoaguChek instruments for POC PT/INR testing since 1994.Today, in the U.S., four out of five PT/INR tests at the point of care are done using the CoaguChek family of products.

The CoaguChek XS system represents the third generation of point-of-care anticoagulation monitoring devices from Roche Diagnostics. The exclusive smart technology of the CoaguChek XS System offers new flexibility and control benefits that healthcare professionals can use to manage in-office prothrombin time (PT/INR) testing more effectively. The CoaguChek XS System is the only anticoagulation monitoring system to perform onboard quality control in the reagent chamber, a feature designed to save time and provide enhanced confidence in the quality of results.1 The system also neutralizes therapeutic levels of heparin and LMW heparin, enabling physicians to do POC testing on a broad range of anti-coagulated patients. The latest CoaguChek system also continues to provide accurate, precise results in just one minute from a small 10 μL drop of blood obtained from a fingerstick.

Performing PT/INR (clotting time) testing at the point of care rather than at an outside lab allows healthcare professionals to make dosage adjustments and talk with patients immediately, to help protect them from potentially serious complications. This offers several benefits over laboratory testing with a venous blood sample, a process that can take up to several hours or even a few days, potentially delaying therapeutic decisions.