Instrumentation Laboratory Launches HemosIL® Apixaban Testing Solution in Europe
BEDFORD, Mass., May 9, 2016 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced the commercialization of their HemosIL Apixaban Testing Solution in Europe. The HemosIL Liquid Anti-Xa assay, when used in conjunction with HemosIL Apixaban Calibrators and Controls* offers an automated solution for measurement of apixaban, a direct oral anticoagulant (DOAC). 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 Apixaban Testing Solution delivers an automated solution with excellent linearity, limit of detection, precision and accuracy, for reliable results that may enhance patient management decisions. Apixaban is a direct factor Xa inhibitor, developed by Pfizer Inc. and Bristol-Myers Squibb Company, and sold under the trademark, Eliquis®.
"The HemosIL Apixaban Testing Solution is the third DOAC-testing solution IL has delivered to the market -- a strong indicator of our deep commitment to innovation in the field of Hemostasis and to improving patient care," said Remo Tazzi, Director Worldwide Hemostasis Marketing at IL. "Our DOAC assay portfolio also offers Hemostasis labs an effective route to better efficiency. Improving patient care, while simultaneously reducing time and cost is a universal mandate for hospitals around the world, and our assays undoubtedly contribute to achieving this goal."
Although monitoring is not required for patients on DOAC therapy, there are exceptions where measurement may be beneficial. These include, in patients who: present to the ER with an adverse event; require immediate reversal of anticoagulation; experience renal or liver failure; have a suspected or known interaction with other drugs; or require verification of pre-operative drug clearance1. The HemosIL Apixaban 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 Apixaban Testing Solution is the third 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 and their HemosIL Rivaroxaban Testing Solution for measurement of rivaroxaban (Xarelto®) in August 2015. The HemosIL Apixaban Testing Solution is not yet 510(k)-cleared by the US FDA and is not currently available in North America.
Today, IL is the leading 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 recent release of its new ACL TOP Family 50 Series Hemostasis Testing Systems with automated pre-analytical sample checks. The ACL TOP Family of fully automated analyzers is the leading Hemostasis product line in the world.
*Not available in all countries. Not FDA-cleared.
1Baglin T, et al. Measuring Oral Direct Inhibitors (ODIs) of thrombin and factor Xa: A recommendation from the Subcommittee on Control of the Scienfitic 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 and GEMweb® Plus Custom Connectivity. The IL Hemostasis portfolio includes new ACL TOP Family 50 Series Hemostasis Testing Systems and the original ACL TOP® Family of Hemostasis Testing Systems, fully automated, high-productivity analyzers. 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. All other product names, company names, marks, logos, and symbols are trademarks of their respective owners.
Eliquis is a registered trademark of Bristol-Myers Squibb Company.Pradaxa is a registered trademark of Boehringer Ingelheim.Xarelto is a registered trademark of Bayer HealthCare AG.
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SOURCE Instrumentation Laboratory