Werfen Receives US FDA 510(K) Clearance for Aptiva® Connective Tissue Disease Essential Reagent

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Oct 16, 2023, 15:00 ET

New Reagent Aids in Diagnosis of Connective Tissue Disease in Hard-to-Diagnose Autoimmune Diseases, Reducing Time to Diagnosis and Improving Patient Outcomes

SAN DIEGO, Oct. 16, 2023 /PRNewswire/ -- Werfen today announced 510(k) clearance of Aptiva^® Connective Tissue Disease (CTD) Essential reagent by the US Food and Drug Administration (FDA).

The Aptiva CTD Essential complements Werfen's previously cleared Aptiva Celiac Disease reagent. In addition to CTD and Celiac Disease assays, Aptiva will target additional autoimmune disease states, and has over 60 analytes in various stages of advanced development. These analytes have the potential to reduce the time to diagnosis of autoimmune diseases and support better patient management.

Aptiva utilizes particle-based multi-analyte technology (PMAT)

"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 Business Development at Werfen. "We are excited to bring this latest expansion of the Aptiva reagent menu to the US market, resulting in advanced patient care."

Aptiva is a fully automated multi-analyte system that represents the next generation of high-throughput multi-analyte systems for the clinical autoimmune laboratory.

The system uses particle-based multi-analyte technology (PMAT), which processes multiple analytes simultaneously from a single patient sample. PMAT enables Aptiva CTD Essential reagent to deliver up to 600 results per hour and allows the laboratory to complete its test volume with minimal hands-on time.

About Werfen

Werfen (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 Autoimmunity, Hemostasis, Acute Care Diagnostics (ACD), and Original Equipment Manufacturing (OEM).

Werfen's solutions help improve the way patients with autoimmune diseases are diagnosed, monitored, and treated. The autoimmunity portfolio includes Aptiva^®, BIO-FLASH^®, NOVA View^®, and QUANTA-Lyser^® 3000 systems, and QUANTA Link^® data management solutions.

The Werfen logo is a trademark of Werfen. Aptiva, QUANTA-Lyser, QUANTA Lite, QUANTA Link, QUANTA Flash, NOVA View, NOVA Lite are registered trademarks of Inova Diagnostics, Inc., a Werfen company, as the legal manufacturer. BIO-FLASH is a registered trademark of Biokit S.A. 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 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 Werfen