FDA grants 510(k) clearance to Werfen’s reagent for connective tissue disease testing
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The FDA has granted 510(k) clearance to Werfen for its Aptiva Connective Tissue Disease Essential reagent to assist in the diagnosis of patients with autoimmune diseases, according to a manufacturer press release.
This clearance complements Werfen’s previously cleared Aptiva Celiac Disease IgG reagent, and broadens the offerings of its Aptiva lab system, an automated, high-throughput system that enables clinical laboratories to process multiple analytes simultaneously from a patient sample.
“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,” Michael Mahler, PhD, vice president of research and business development at Werfen, said in a press release. “We are excited to bring this latest expansion of the Aptiva reagent menu to the U.S. market, resulting in advanced patient care.”
The company noted that the Aptiva lab system uses particle-based multi-analyte technology, which allows the Aptiva CTD Essential reagent to deliver up to 600 results per hour and enables the laboratory to complete its test volume “with minimal hands-on time.”
Building on the current CTD and celiac disease assays, Werfen in the release noted that it intends to target other autoimmune diseases, with more than 60 analytes currently in advanced development that have the potential to reduce the time to diagnosis and support improved patient management.
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