Instrumentation Laboratory (IL) announced the commercialization of their HemosIL Rivaroxaban Testing Solution in Europe.
The HemosIL Liquid Anti-Xa assay, when used in conjunction with HemosIL Rivaroxaban Calibrators and HemosIL Rivaroxaban controls offers an automated solution for measurement of rivaroxaban.
The assay, calibrators and controls are CE IVD Marked under the European IVD Directive 98/79/EC. This Mark allows IL to distribute the HemosIL Rivaroxaban Testing Solution in the European Union and other international territories.
Fully validated for use on the ACL TOP Hemostasis Testing Systems, the HemosIL Rivaroxaban Testing Solution delivers an automated solution with excellent linearity, precision and accuracy, for reliable results that may enhance patient management decisions.
Rivaroxaban is an oral anticoagulant, direct factor Xa inhibitor, developed by Bayer HealthCare and sold under the trademark Xarelto.
"Twenty-five percent of people over 40 are projected to develop Atrial Fibrillation (AF) in their lifetime1. As the incidence of AF increases, the need for high quality testing solutions to measure DOAC levels in the blood is essential," said Remo Tazzi, Director Worldwide Hemostasis Marketing at IL.
Although monitoring is not required for patients on DOAC therapy, there are exceptions where measurement may be beneficial. These include, in patients who: present with bleeding; require reversal of anticoagulation; require surgery or an invasive procedure and have taken the drug within 24 hours, or longer if creatinine clearance is < 50 mL min-1; experience deteriorating renal function.
The HemosIL Rivaroxaban Testing Solution provides labs with a consistent, efficient and accurate testing solution to inform patient management decisions in these and other clinical scenarios.
The HemosIL Rivaroxaban Testing Solution is the second assay IL has commercialized in their DOAC Assay Panel, following the introduction of their HemosIL Direct Thrombin Inhibitor Assay for measurement of dabigatran (Pradaxa) in September 2014.