Werfen Announces CE Mark for Aptiva CTD Essential Reagent

SAN DIEGO, Dec. 2, 2021 /PRNewswire/ -- Werfen, a worldwide leader in specialized diagnostics for autoimmune disease, is pleased to announce the CE Mark of Aptiva^® CTD Essential Reagent for use on the Aptiva^® system. Aptiva is a fully automated multi-analyte system that represents the next generation of high throughput instruments for the clinical laboratory. 

Aptiva addresses many health economic shortcomings in the autoimmune laboratory. Existing systems provide a limited number of analytes that leave a significant seronegative gap found in many disease states. Aptiva will cover several autoimmune disease states and has over 60 analytes in various stages of advanced development. These analytes have the potential to help clinicians close the seronegative gap and improve diagnostic confidence.

Aptiva also provides economic benefits for the laboratory. The 150-sample rack capacity and a 6.5-hour consumable walkaway time delivers new levels of workflow efficiencies by reducing the number of daily interventions. Aptiva uses a digital particle-based multi-analyte technology (PMAT), that processes multiple analytes simultaneously from a patient sample. PMAT enables Aptiva CTD Essential Reagent to deliver up to 660 results per hour and allows the laboratory to complete its test volume with minimal hands-on time.

"Aptiva CTD Essential with its unique biomarker composition and high level of analytical and clinical performance represents a breakthrough that fundamentally enhances the utility of diagnostic testing in the autoimmune laboratory," said Michael Mahler, PhD., Vice President of Research and Development at Werfen. "Aptiva CTD Essential will deliver expanded information to clinicians for management of patients with autoimmune diseases."

For more information about Aptiva, please contact your local Werfen Representative.

About Werfen

Werfen (www.werfen.com), founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's business lines include Hemostasis, Acute Care Diagnostics (ACD), Autoimmunity, and Original Equipment Manufacturing (OEM). Werfen's Hemostasis portfolio includes ACL TOP^® Family 50 Series and ACL TOP Family Hemostasis Testing Systems, ACL AcuStar^® system, ACL Elite^® systems, HemoCelltm Specialized Lab Automation, HemoHubtm Intelligent Data Manager, along with the comprehensive line of HemosIL^® assays. The ACD portfolio includes the GEM^® Premiertm 5000 system with Intelligent Quality Management 2 (iQM^®2), GEM Premier 3500 system with iQM, GEM Premier ChemSTATtm system, GEMweb^® Plus Custom Connectivity, ROTEM^® viscoelastic testing systems, Hemochrontm systems, VerifyNowtm platelet function testing system, and Avoximetertm CO-Oximeters. The Autoimmunity portfolio includes Aptiva^®, BIO-FLASH^®, NOVA View^®, AUTOLoader and QUANTA-Lyser^® 3000 systems, and QUANTA Link^® data management solutions. The OEM business line offers services for end-to-end development and manufacturing of customized immunoassays and biomaterials for diagnostic companies.

The Werfen logo is a trademark of Werfen. GEM, Premier, GEM Premier ChemSTAT, GEMweb, iQM, ChemSTAT, HemosIL, ACL, ACL TOP, ACL Elite, ACL AcuStar, ReadiPlasTin, RecombiPlasTin, SynthASil, SynthAFax, ROTEM, Hemochron, VerifyNow and Avoximeter are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or its parent company. Aptiva, QUANTA-Lyser, QUANTA Lite, QUANTA Link, QUANTA Flash, NOVA View, NOVA Lite are registered trademarks of Inova Diagnostics, Inc., a part of Werfen, as the legal manufacturer. BIO-FLASH is a registered trademark of Biokit S.A. All other product names, company names, marks, logos, and symbols are trademarks of their respective owners.

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