FDA clears Thermo Fisher autoimmune disease tests

2022 06 09 18 00 5852 Lab Blood Samples 400

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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