Areas of Research

Autoimmune Technologies has developed and patented the Anti-Polymer Antibody Assay, or APA Assay, as the first laboratory test for fibromyalgia.

Fibromyalgia was defined in 1990 by the American College of Rheumatology (the "ACR") as a syndrome characterized by widespread musculoskeletal pain and the presence of tenderness or pain in eleven or more of eighteen specific "tender points" on the body. Nearly all fibromyalgia patients also experience severe fatigue, stiffness, skin tenderness, fragmented sleep, and pain that follows physical exertion. Many fibromyalgia patients have other symptoms as well, including tension-type headaches, cold intolerance, poor memory, dryness of the eyes, mouth or other mucous membranes, unexplained bruising, fluid retention, chest, jaw or abdominal pain, irritable bowel syndrome, bladder irritation, breathing difficulty, dizziness, paresthesias, and low-grade depression and anxiety. The ACR criteria do not address any of these other symptoms because their presence was not found to assist significantly in establishing a fibromyalgia diagnosis in severe cases.

The research conducted by Autoimmune Technologies has shown that the APA Assay detects anti-polymer antibodies in the blood of the majority of fibromyalgia patients and that the titers (amounts) of these antibodies correlate with the severity of a variety of the patients' fibromyalgia symptoms, including headache, stiffness, anxiety and depression. The presence of these antibodies is the first evidence to indicate that fibromyalgia patients mount an immunological response that is associated with their disorder, and the antibodies represent the first objective laboratory marker for fibromyalgia. Indeed, the discovery of these antibodies will probably help convince skeptical physicians that fibromyalgia is a "real disease" and not a psychologically-based condition as many now believe it to be.

Fibromyalgia occurs much more frequently in women than in men, and it affects as many as three to five percent of the women in the United States. Similar levels of incidence may occur in other countries. In addition, perhaps ten percent to fifteen percent or more of adult U.S. women exhibit fibromyalgia-like symptoms which include from six to ten tender points but fall short of the eleven tender points required for a clinical diagnosis of fibromyalgia under the ACR criteria.

Though no one is certain, fibromyalgia appears to have multiple causes. The majority of patients experience a gradual onset of symptoms which become increasingly noticeable over time, although some patients associate physical trauma to the head or neck, a period of persistent stress, a bout with another disease such as Lyme disease, or another specific event with the beginning of their symptoms. Correlation between an event and the onset of a disease does not mean that the event caused the disease, however, and the nature and diversity of the symptoms of fibromyalgia, the similarity of some of those symptoms to the symptoms of other rheumatic diseases, the absence until this time of a laboratory test for the disorder, and other factors have all contributed to making fibromyalgia a difficult condition to diagnose.

The Company is conducting FDA clinical trials of the APA Assay and expects it to be useful as an aid in the diagnosis of fibromyalgia patients, in differentiating fibromyalgia patients from patients with other autoimmune diseases such as lupus (SLE), and in identifying those fibromyalgia patients who are manifesting this unique, symptom-associated immune response.

For information about our research, see the Science Summary page. For APA Assay FAQs and information about the availability of the APA Assay, see the Fibromyalgia Test page. The Corgenix Medical Corporation's press release of August 19, 2004 discussing the APA ELISA Test Kit can be found on the News Releases page.