Instrumentation Laboratory Receives US FDA Marketing Authorization For The First Apixaban Diagnostic Test

On September 22, 2020 Instrumentation Laboratory (IL) reported that the US Food and Drug Administration (FDA) granted De Novo marketing authorization for the HemosIL Liquid Anti-Xa test kit to measure apixaban (Press release, Instrumentation Laboratory, SEP 22, 2020, View Source [SID1234565502]). This is the first direct oral anticoagulant (DOAC) test for automated Hemostasis analyzers authorized by the FDA.

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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.

"DOACs are essential treatment for hundreds of thousands of patients around the world. Providing a means for clinicians to assess appropriate patients who take apixaban is an important step in enhancing care," said Remo Tazzi, Director, Worldwide Marketing at IL. "We are very proud to add another milestone "first" to our 60-year history of innovation in in vitro diagnostics."

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.

The HemosIL Liquid Anti-Xa assay is not a stand-alone test and the results should be used in conjunction with other clinical and laboratory findings. Apixaban is a direct factor Xa (FXa) inhibitor, developed by Pfizer Inc. and Bristol-Myers Squibb Company, and is sold under the trademark Eliquis.