Phadia US Inc., the Portage-based United States division of the Swedish laboratory gear firm, said Thursday it had received U.S. Food and Drug Administration clearance for eight new autoimmune antibody assays.
These new assays will provide physicians the tools needed to further differentiate a positive ANA screen and guide them to a more specific Connective Tissue Disease diagnosis. The newly available EliA individual ENA assays now give physicians a very specific follow up option to confirm and further refine a positive result with Phadia’s EliA Symphony ANA Screen or other ANA screening assay.
The newly cleared, CLIA Moderate Complexity, assays announced today provide semi-quantitative results for the presence of ENA antibodies to the following antigens: Sm, U1RNP, RNP70, Ro, La, Scl-70, CENP and Jo-1. The presence of these very specific antibodies support or help confirm the diagnosis of specific CTDs. These diseases are complex and often difficult to diagnose. With these new individual ENA assays, clinicians now have a complete array of Phadia tools to aid in the diagnosis and evaluation of a range of CTDs such as lupus, Sjogren’s syndrome, systemic sclerosis, limited systemic sclerosis, poly-dermatomyositis, and mixed connective tissue disease.
Michael Land, President of Phadia US, says, “Since its inception in 1967, Phadia has set the standard in the detection and diagnosis of allergies. Now, with the continued expansion of our product line in the United States, we are providing clinicians with the same standard providing diagnostic tools to support the diagnosis of autoimmune diseases such as connective tissue diseases.”
Autoimmune diseases impact an estimated 46 million patients per year in North America. These diseases pose a significant diagnostic challenge for clinicians because the presence of autoantibodies strongly relate to one or more CTDs. With ENA antibody assays from Phadia, clinicians can help confirm their diagnosis of specific CTDs.
More at www.phadia.com.
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