PORTAGE, Mich.--(BUSINESS WIRE)--Today Phadia announced that it has received FDA clearance for 8 new EliA ENA 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 (CTD) 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 1 or more CTDs. With ENA antibody assays from Phadia, clinicians can help confirm their diagnosis of specific CTDs.
The clearances announced today extend Phadia’s product line of CLIA Moderately Complex assays in the EliA autoimmune product line. Other commercially-available EliA assays include Cyclic Citrullinated Peptide (CCP), tissue Transglutaminase (tTG) IgA and IgG (Celikey®), Gliadin IgA and IgG, dsDNA, and Extractable Antinuclear Antibody IgG (Symphony).
The EliA assays are available on the Phadia Laboratory Systems ImmunoCAP® 100? and ImmunoCAP 250 and feature a quick turnaround time, are performed under master IgG curves with monthly calibration, have on board instrument dilution capability, and are performed using a discrete, single well, random access, non-microtiter plate format.
About Phadia
Phadia is setting the standard as the global leader in allergy and autoimmune blood testing. The ImmunoCAP® Specific IgE blood test delivers Results You Can Trust. The accuracy, precision and clinical utility of ImmunoCAP is supported in over 3,000 peer-reviewed publications. EliA autoimmune assays represent Excellence in Autoimmunity. The fully automated, cutting edge Phadia Laboratory System technology platforms offer walk away convenience. We invite you to learn more about the EliA autoimmune assays as well as why the ImmunoCAP Specific IgE blood test is the worldwide leader for serologic, specific IgE testing by visiting www.phadia.com.
