Werfen unveiled a significant development in the form of a 510(k) clearance for their Aptiva® Connective Tissue Disease (CTD) Essential reagent by the US Food and Drug Administration (FDA).

Aptiva CTD Essential serves as a valuable complement to Werfen's previously cleared Aptiva Celiac Disease reagent. Going beyond CTD and Celiac Disease assays, Aptiva is poised to address a range of autoimmune disease conditions, boasting a portfolio of over 60 analytes in various stages of advanced development. These analytes hold immense potential in expediting the diagnosis of autoimmune diseases and enhancing patient care.

Aptiva CTD Essential distinguishes itself through its unique biomarker composition and exceptional analytical and clinical performance, heralding a transformative era in diagnostic testing within autoimmune laboratories. Aptiva represents an innovative, fully automated multi-analyte system that marks a significant leap in high-throughput multi-analyte systems for clinical autoimmune laboratories.

The system harnesses particle-based multi-analyte technology (PMAT) to simultaneously process multiple analytes from a single patient sample. This cutting-edge approach empowers Aptiva CTD Essential reagent to deliver an impressive throughput of up to 600 results per hour, streamlining the testing process while reducing the need for extensive hands-on involvement from laboratory personnel.

Source: prnewswire.com