FDA clears Thermo Fisher autoimmune disease tests

By LabPulse.com staff writers

June 9, 2022 -- Thermo Fisher Scientific on Thursday announced that the U.S. Food and Drug Administration (FDA) has cleared its EliA RNA Pol III and EliA Rib-P blood tests to diagnose systemic sclerosis and systemic lupus erythematosus.

The Waltham, MA-based firm said EliA RNA Pol III is the first fully automated RNA polymerase test for systemic sclerosis available in the U.S. Its EliA Rib-P test can be used to support the diagnosis of systemic lupus erythematosus, particularly in antinuclear antibody-negative patients.

RNA polymerase III is a criteria marker for systemic sclerosis with both diagnostic and prognostic value. Up to 70% of the patients who test positive for RNA polymerase III may have no other systemic sclerosis-associated antibodies present, Thermo Fisher said.

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Last Updated mp 6/9/2022 11:25:38 AM