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FDA Clears Thermo Fisher Scientific Tests to Help Diagnose Systemic Sclerosis, Lupus

NEW YORK – Thermo Fisher Scientific said on Thursday that the US Food and Drug Administration has cleared its Thermo Scientific EliA RNA Pol III and EliA Rib-P tests for aiding in the diagnosis of systemic sclerosis (SSc) and systemic lupus erythematosus (SLE).

RNA polymerase III antibodies are a marker for SSc and have both diagnostic and prognostic value. Up to 70 percent of patients testing positive for these antibodies have no other SSc-associated antibodies present.

A subset of SLE patients have monospecific ribosomal P antibodies, which the EliA Rib-P test can detect with high sensitivity and specificity, according to the company.

"The new EliA RNA Pol III and EliA Rib-P tests have been designed to improve the differentiation of SSc and SLE from other connective tissue diseases," said Henry Homburger, director of the Thermo Fisher Phadia Immunology Reference Laboratory, in a statement. "Targeting existing diagnostic care gaps can potentially lead to earlier and more accurate diagnosis and ultimately improve clinical outcomes for patients."

Last year, the FDA already cleared the Thermo Scientific EliA SmDP-S test, which detects antibodies to the SmD3 peptide, to help in the diagnosis of SLE.