BEDFORD, Mass., Aug. 10, 2015 /PRNewswire/ -- Instrumentation Laboratory (IL) today 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. "With the launch of our second DOAC testing solution, IL remains focused on delivering quality assays to help improve clinical management and patient care, as well as on helping our customers improve efficiency in their labs."
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 function2. 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. Today, IL is the number one manufacturer of instruments and reagents for the hemostasis market worldwide. IL has continually been at the forefront of innovation in hemostasis testing, culminating in the release of its ACL TOP Family Hemostasis Testing Systems. This line of fully automated analyzers is the leading Hemostasis product line in the world.
1 Lloyd-Jones DM, Wang TJ, Leip E, et al. Lifetime risk for development of atrial fibrillation. Circulation. 2004;110:1042-1046
2 Baglin T, et al. Measuring Oral Direct Inhibitors (ODIs) of thrombin and factor Xa: A recommendation from the Subcommittee on Control of the Scientific and Standardisation Committee of the ISTH. J Thromb Haemost. 2013;11:756-60
Instrumentation Laboratory (www.instrumentationlaboratory.com), founded in 1959, is a worldwide developer, manufacturer and distributor of in vitro diagnostic instruments, related reagents and controls for use primarily in hospitals and independent clinical laboratories. The Company's product lines include Critical Care systems, Hemostasis systems and Information Management systems. IL's GEM® product offerings, part of the Critical Care line, include the GEM Premier™ 4000 analyzer with Intelligent Quality Management (iQM®), GEM Premier 3500, GEMweb® Plus Custom Connectivity, and GEMdraw arterial blood samplers. The IL Hemostasis portfolio includes the ACL TOP® Family of Hemostasis Testing Systems, fully automated, high-productivity analyzers, comprised of the ACL TOP 700, ACL TOP 700 LAS, ACL TOP 700 CTS, ACL TOP 500 CTS and ACL TOP 300 CTS and new ACL TOP 750, ACL TOP 750 LAS, ACL TOP 750 CTS, ACL TOP 550 CTS and ACL TOP 350 CTS systems. IL also offers the ACL AcuStar®, ACL ELITE®, and other Hemostasis analyzers, along with the comprehensive HemosIL® line of reagents. IL is based in Bedford, Massachusetts.
The Instrumentation Laboratory logo, GEM, GEMweb, iQM, HemosIL, ACL, ACL TOP, ACL ELITE, ACL AcuStar and Premier are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies, and may be registered in the United States Patent and Trademark Office and in other jurisdictions. Xarelto is a registered trademark of Bayer HealthCare AG. All other product names, company names, marks, logos, and symbols are trademarks of their respective owners.
SOURCE Instrumentation Laboratory