Instrumentation Laboratory Launches Fully Automated HemosIL® AcuStar VWF Assay Panel In Europe And International Territories
BEDFORD, Mass., Feb. 5, 2013 /PRNewswire/ — Instrumentation Laboratory (IL) today announced the release of their new HemosIL AcuStar von Willebrand Factor (VWF) assay panel as a European CE IVD Mark product under the European Directive on in vitro Diagnostic Medical Devices. The CE IVD Mark allows IL to commence distribution of the product in the European Union and other international territories. The fully automated HemosIL AcuStar VWF assay panel, designed exclusively for use on the ACL AcuStar(®) Hemostasis Testing System, includes HemosIL AcuStar VWF Antigen (VWF:Ag) and HemosIL AcuStar VWF Ristocetin Cofactor (VWF:RCo) Activity assays.
This new panel automates and simplifies laboratory testing for von Willebrand disease (VWD), a key part of clinical investigation. Moreover, HemosIL AcuStar VWF:RCo is the first fully automated, chemiluminescent assay to use recombinant technology, allowing full automation and greater precision than platelet-based tests. It meets guidelines on VWD investigation and enhances accuracy versus manual methods. Additionally, chemiluminescence offers an enhanced linearity range to quantify extremely low levels of VWF concentrations.
“With the ACL AcuStar Hemostasis Testing System, our goal is to automate complex assays and offer enhanced efficiency and sensitivity where it matters most,” said Remo Tazzi, Director of Hemostasis Marketing at IL. “Our new HemosIL AcuStar VWF assays achieve this, allowing clinicians to make quicker and more effective patient care decisions.”
Like all reagents on the ACL AcuStar System, HemosIL AcuStar VWF assays are ready-to-use, cartridge-based and offer results in 30 minutes–on-demand, 24/7. This is the third specialty assay panel commercialized on the ACL AcuStar system. Previously introduced panels include Antiphospholipid Syndrome and Heparin-Induced Thrombocytopenia.
About Von Willebrand Disease (VWD)
VWD is an acquired or inherited bleeding disorder, caused by a qualitative or quantitative defect of the VWF protein. In contrast to hemophilia, which mainly affects males, VWD is not gender-specific. The disease affects over 1% of the worldwide population and occurs in 1/100-100,000 people with hemophilia. Acquired VWD can be associated with serious autoimmune problems (e.g., rheumatoid arthritis, systemic lupus erythematosus, and specific types of kidney failure or cancers) and may develop with no underlying conditions. Certain kinds of VWD may remain undiagnosed because symptoms can be mild. Prompt diagnosis and classification are necessary for optimal therapeutic management.
HemosIL AcuStar VWF and HemosIL AcuStar HIT assays are not currently 510(k) cleared.
Instrumentation Laboratory ( www.ilus.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(TM) 4000 analyzer with Intelligent Quality Management (iQM(®)), GEM Premier 3500, GEMweb® Plus Custom Connectivity, and complementary products GEM PCL Plus, a portable coagulation analyzer, GEM OPL CO-Oximeter, and GEMdraw arterial blood samplers. IL’s Hemostasis portfolio includes the ACL TOP(®) Family of Hemostasis Testing Systems, fully automated, high-productivity analyzers, including the ACL TOP 700, ACL TOP 700 LAS, ACL TOP 700 CTS, ACL TOP 500 CTS and ACL TOP 300 CTS. IL also offers the ACL AcuStar(®), ACL ELITE(®), other Hemostasis analyzers and the HemosIL(®) line of reagents. IL is based in Bedford, Massachusetts.
The Instrumentation Laboratory logo, GEM, 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.
SOURCE Instrumentation Laboratory