The patented Anti-Polymer Antibody Assay, or APA Assay, detects anti-polymer antibodies in the blood of most patients with fibromyalgia and fibromyalgia-like symptoms. Research has shown that the titers of these antibodies correlate with various clinical measures of fibromyalgia severity, including headache, fatigue, anxiety and depression. This and other research data strongly suggests that fibromyalgia is associated with an abnormal immune-system response in these patients.
Autoimmune Technologies believes the APA Assay to be the first practical laboratory test for fibromyalgia. The Company expects the test to be useful (i) in assisting physicians in diagnosing fibromyalgia, (ii) in assisting physicians in differentiating fibromyalgia patients from patients with lupus (SLE) and other disorders having similar early-stage symptoms, and (iii) in identifying those fibromyalgia patients in whom a symptom-associated immune response is present so that physicians can further monitor immune-system involvement and consider attempting to modulate it using existing drugs or other means.
The Company is conducting clinical trials of the APA ELISA Kit for submission to the U.S. Food and Drug Administration. The kit is now available for purchase and use outside the U.S. but cannot be sold in the U.S. during the clinical trial period. Physicians and researchers inside or outside the U.S. who are interested in research use of the
APA Assay may request that the test be run on a per-patient basis in a qualitative, strip-assay format. The Corgenix Medical Corporation press release of August 19, 2004 discussing the
APA ELISA Kit can be found on the News Releases page.
Click on the links below for scientific information, ordering information and questions and answers about the
APA Assay.
FREQUENTLY ASKED QUESTIONS ABOUT THE APA
ASSAY
ADDITIONAL INFORMATION ABOUT THE APA ASSAY
Go to the Fibromyalgia Research
Page.
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