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CLIA waiver for Roche's POC anticoagulation monitor

This article was originally published in Clinica

Executive Summary

Roche Diagnostics' CoaguChek XS Plus system, a point-of-care (POC) anticoagulation monitor, has been granted CLIA-waiver status by the US FDA. This means that the device can now be used in a broader range of clinical settings, rather than just those labs that are permitted to carry out moderate- or high-complexity testing under CLIA regulations. Anticoagulation testing is used to help adjust doses of anticoagulant drugs such as warfarin, as effective doses can vary widely between patients, and also in the same patient over time. Roche first launched CoaguChek XS Plus, which provides results in "about a minute", in 2006.

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