First FDA Approved DOAC Assay
US FDA Marketing Authorisation for Apixaban Diagnostic Test―The First Direct Oral Anticoagulant Test for Automated Hemostasis Systems
U.K. - October 19, 2020
Werfen has received US FDA marketing authorisation for the first direct oral anticoagulant (DOAC) test in the US market.
The HemosIL Liquid Anti-Xa test kit to measure Apixaban will be the first test of its kind commercialised in the US. The test is already available in the UK, EU and other markets.
The FDA indication for HemosIL Liquid Anti-Xa has been expanded from the current quantitative determination of unfractionated heparin and low molecular-weight heparin, to include apixaban measurement, when used with HemosIL Apixaban Calibrators. The test is intended to measure apixaban concentrations in patients on apixaban therapy in the following situations where measurement of apixaban levels could be useful to have as additional information: patients at risk for major bleeding and patients experiencing a bleeding episode.
In the fight against COVID-19, we have seen anticoagulant treatments come to the fore in the prevention of COVID related thrombotic events. HemosIL Liquid Anti-Xa has provided our UK customers with accurate and reliable monitoring of Unfractionated and Low Molecular Weight Heparin and DOAC levels. With its proven track record and liquid ready to use format, this is the assay of choice for laboratories needing fast and accurate results when treating patients.
Fully validated for use on the ACL TOP® Family and ACL TOP Family 50 Series Hemostasis Testing Systems, HemosIL Liquid Anti-Xa assay for apixaban measurement delivers an automated result with excellent linearity, limit of detection, precision and accuracy, for reliable results and enhanced patient management.
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