FDA Clears Automated Diagnosis Tests for Lupus and ANCA-associated Vasculitis

The U.S. Food and Drug Administration (FDA) has approved new automated diagnostic tests for lupus and ANCA-associated vasculitis, a form of blood vessel inflammation, Grifols, which will market these tests, announced.

The two use 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. This will allow labs to standardize and speed diagnosis of these autoimmune diseases using antibody detection, considered the gold-standard method.

In a clinical setting, faster and accurate diagnosis can translate to lower costs and better patient outcomes.

The tests use fluorescent antibodies to detect markers of disease in a patient’s blood sample. Because the tests pair immune-system-produced antibodies with fluorescence, the approach is called immunofluorescence assay (IFA).

Anti-nuclear antibodies, particularly those against double-stranded DNA (anti-dsDNA antibodies), are a common feature of systemic lupus erythematosus. The new automated test for lupus, called nDNA, is an indirect immunofluorescence assay that detects anti-dsDNA antibodies in the serum of lupus patients.

The FDA also approved the AESKUSLIDES ANCA to help diagnose all subtypes of ANCA-associated vasculitis, including granulomatosis with polyangiitis, microscopic polyangiitis, and eosinophilic granulomatosis with polyangiitis.

This follows the approval of an additional HELIOS immunofluorescence assay – ANA HEp-2 – which uses a combination of anti-nuclear fluorescent antibodies to detect systemic lupus erythematosus, scleroderma, mixed connective tissue disease, primary Sjögren’s syndrome, and other autoimmune diseases.

“The recent approvals by the U.S. Food & 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,” Carsten Schroeder, president of Grifols Diagnostic Division, said in a press release.

“The addition of these assays to our current portfolio, which includes ANA HEp-2, enable our customers performing IFA to detect anti-dsDNA and ANCA using one automated, IFA platform. With these assays approved, the HELIOS now has the largest FDA cleared IFA menu of any IFA reader,” Schroeder added.

Grifols, which specializes in diagnostic solutions, is the exclusive distributor of HELIOS and AESKU autoimmune disease diagnostic tests in the U.S. The company expects to begin marketing the AESKUSLIDES ANCA and nDNA in the U.S. early this summer.

The AESKU group will present the HELIOS system and FDA’s-approved diagnostic test kits at the American Association of Clinical Chemistry’s 70th annual meeting, taking place in Chicago from July 29 to Aug. 2