Werfen Secures FDA 510(K) Clearance for Aptiva® Tissue Disease Reagent

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

Werfen  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 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.