Thermo Fisher Scientific Inc (NYSE:TMO) reported on Thursday the receipt of approval from the US Food and Drug Administration (FDA) for its EliA SmDP-S blood test for aiding the diagnosis of Systemic Lupus Erythematosus (SLE), the most common type of lupus.
According to the company, 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 test replaces the former SmDP test.
SLE is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. It can affect the joints, skin, brain, lungs, kidneys and blood vessels. There is no cure for lupus, but medical interventions and lifestyle changes can help.
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