Werfen has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Aptiva Connective Tissue Disease (CTD) Essential reagent.

According to the specialised diagnostic instruments manufacturer, the Aptiva CTD Essential expands upon its existing cleared Aptiva Celiac Disease reagent.

Beyond CTD and Celiac Disease assays, Aptiva aims to address further autoimmune disease conditions, with more than 60 analytes in advanced development stages. The analytes hold the potential of expediting autoimmune disease diagnosis and enhancing patient care, said Werfen.

Werfen research and business development vice president Michael Mahler said: ÔÇťAptiva 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.

“We are excited to bring this latest expansion of the Aptiva reagent menu to the US market, resulting in advanced patient care.”

Aptiva is designed as a fully automated multi-analyte system. It represents the next generation of high-throughput multi-analyte solutions for clinical autoimmune laboratories, said the company.

Powered by particle-based multi-analyte technology (PMAT), the system simultaneously handles multiple analytes from a single patient sample. PMAT empowers the Aptiva CTD Essential reagent to generate a throughput of up to 600 results per hour to streamline laboratory operations with minimal manual intervention.

Established in 1966, Werfen operates across various business segments, encompassing autoimmunity, haemostasis, acute care diagnostics (ACD), and original equipment manufacturing (OEM).

Earlier this year, Werfen completed the acquisition of Immucor, a US-based company specialising in in vitro diagnostics (IVD) and with a worldwide footprint in the transfusion and transplant sectors.