Werfen Receives FDA Approval for Aptiva® CTD Essential Reagent

Barcelona-based Werfen has received US FDA 510(k) clearance for its Aptiva® Connective Tissue Disease (CTD) Essential reagent, a fully automated multi-analyte system using particle-based multi-analyte technology (PMAT) to simultaneously process multiple analytes from a single patient sample.

PMAT enables the Aptiva CTD Essential reagent to deliver up to 600 results per hour, allowing the laboratory to complete its testing volume with minimal hands-on time.

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, VP of Research and Business Development at Werfen.

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