FDA Approves Diagnostic Test for Lupus and ANCA-Associated Vasculitis

New automated diagnostic tests for lupus and ANCA-associated vasculitis, a form of blood vessel inflammation, have been approved by the U.S. Food and Drug Administration (FDA). Both tests use fluorescent antibodies to detect markers of disease in a patient’s blood sample utilizing the HELIOS system (developed by AESKU), which is the first and only automated system capable of processing and analyzing a patient’s blood sample in a single run.

The new automated test for lupus, called nDNA, is an indirect immunofluorescence assay (IFA) that detects antidsDNA antibodies in the serum of lupus patients. The second test, known as the AESKUSLIDES ANCA, will help diagnose ANCA-associated vasculitis, including granulomatosis with polyangiitis, microscopic polyangiitis and eosinophilic granulomatosis with polyangiitis.

Grifols is the exclusive distributor of both diagnostic tests. “The recent approvals by the U.S. Food and Drug Administration of the ANCA and nDNA assays provide clinical laboratories with an efficient and reliable way to test for autoimmune diseases such as vasculitis and lupus,” said Carsten Schroeder, president of Grifols Diagnostic Division. “The addition of these assays to our current portfolio … enables our customers performing IFA to detect anti-dsDNA and ANCA using one automated IFA platform.”