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FDA Clears Thermo Fisher Scientific Lupus Diagnostic Test

NEW YORK – Thermo Fisher Scientific said on Thursday that its Thermo Scientific EliA SmDP-S test has been cleared by the US Food and Drug Administration for aiding in the diagnosis of systemic lupus erythematosus (SLE).

This new assay, which will replace the company's former SmDP test for the detection of SLE, enhances specificity while keeping the same level of sensitivity, Thermo Fisher said. This leads to a more precise diagnosis and a lower number of false positives.

The EliA SmDP-S test uses a coating technique optimized for binding the synthetic SmD3 peptide antigen, which contains the most specific epitope for Sm peptide antibodies that are highly specific to SLE. Antibodies that react with the SmD3 peptide do not cross-react with other Sm peptides, which improves the specificity of the test for distinguishing SLE from mixed connective tissue disease, which has signs and symptoms of a combination of disorders such as lupus, scleroderma, and polymyositis.

"Existing serologic tests have less than ideal diagnostic specificity for SLE. With the new EliA SmDP-S assay, clinicians can have greater confidence for differentiating SLE from mixed connective tissue disease, because of the improved immuno-chemical specificity," Henry Homburger, professor emeritus of laboratory medicine at the Mayo Clinic College of Medicine, said in a statement.