FDA clears Thermo Scientific blood test for use in U.S.

Thermo Scientific EliA SmD^P-S test has been cleared by the U.S. Food & Drug Administration (FDA) for aiding the diagnosis of Systemic Lupus Erythematosus (SLE), the most common type of lupus. This new test enhances specificity without sacrificing sensitivity, leading to a more precise diagnosis while also reducing the number of false positives.

“Diagnosing autoimmune diseases is often challenging,” said Dr. Henry Homburger, Professor Emeritus of Laboratory Medicine at Mayo Clinic College of Medicine. “Existing serologic tests have less than ideal diagnostic specificity for SLE. With the new EliA SmD^P-S assay, clinicians can have greater confidence for differentiating SLE from mixed connective tissue disease, because of the improved immuno-chemical specificity. This innovative test in turn, has the potential to improve treatment and outcomes for patients with SLE.”

The EliA SmD^P-S utilizes an advanced coating technique optimized for binding the synthetic SmD3 peptide antigen, which contains the most specific epitope for Sm peptide antibodies. Antibodies that react with SmD3 peptide do not cross react with other Sm peptides, which improves the specificity of this test for distinguishing SLE from MCTD².

“The new EliA SmD^P-S replaces the former SmDP test to become a best-in-class test for the detection of Sm antibodies, providing clinicians with a higher degree of diagnostic confidence,” said Dr. Homburger. “With its improved specificity, EliA SmD^P-S could be used to further evaluate potential associations with systemic complications, including nephritis.”