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Diagnostics FDA

 News Release - August 26, 2021

FDA Clears Thermo Scientific EliA SmD(P)-S Test For Use In U.S.

New blood test is designed to reduce the number of false positive results and provide improved diagnostic guidance in Systemic Lupus Erythematosus

PORTAGE, Mich., Aug. 26, 2021 -- (Healthcare Sales & Marketing Network) -- Thermo Scientific EliA SmDP-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 positives1.

"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 SmDP-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 SmDP-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 SmDP-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 SmDP-S could be used to further evaluate potential associations with systemic complications, including nephritis."

For more information on the Thermo Scientific EliA SmDP-S test, please visit

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit
  1. Mahler M et al. Improved Serological Differentiation between Systemic Lupus Erythematosus and Mixed Connective Tissue Disease by Use of an SmD3 Peptide-Based Immunoassay. Clin and Diag Lab Immunol. Jan. 2005, p. 107-113. (LINK)
  2. Mahler M et al. Identification of a SmD3 epitope with a single symmetrical dimethylation of an arginine residue as a specific target of a subpopulation of anti-Sm antibodies. Arthritis Res Ther 2005, 7:R19-R29. (LINK)

Source: Thermo Fisher Scientific

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