Werfen has officially announced the clearance of Aptiva® Connective Tissue Disease (CTD) Essential reagent by the US Food and Drug Administration (FDA), marking a significant milestone in the field of diagnostic testing. This essential reagent complements Werfen's previously approved Aptiva Celiac Disease reagent, expanding the company's diagnostic product offerings. Aptiva is poised to target various autoimmune disease states, with more than 60 analytes currently in advanced development stages.
These analytes hold great potential in expediting the diagnosis of autoimmune diseases and improving patient care. Aptiva CTD Essential is distinctive due to its unique biomarker composition and its exceptional analytical and clinical performance, representing a major breakthrough in autoimmune laboratory diagnostics.
Aptiva is a fully automated multi-analyte system that represents the next generation of high-throughput multi-analyte systems for clinical autoimmune laboratories. It utilizes particle-based multi-analyte technology (PMAT) to process multiple analytes simultaneously from a single patient sample. PMAT allows the Aptiva CTD Essential reagent to deliver up to 600 results per hour while reducing the need for manual intervention in the laboratory.
Source: https://www.prnewswire.com/news-releases/werfen-receives-us-fda-510k-clearance-for-aptiva-connective-tissue-disease-essential-reagent-301957653.html
