Sent March 5, 1998
From
Jan McCoy Hutchinson, (520) 748-4458
Research Corporation Technologies
101 N. Wilmot Rd., Suite 600
Tucson, AZ 85711-3365
(520) 748-4458 (direct)
(520) 748-0025 fax
E-mail: [email protected]
At Last, a Reliable Diagnostic for Rheumatoid Arthritis
A new immunoassay may help physicians identify rheumatoid arthritis (RA) earlier and begin treatment to prevent or postpone the debilitating and costly consequences of the disease. The test also may remove much of the guesswork from managing patients with severe forms of RA.
Dr. Ramesh K. Prakash, a scientist with Theratech Inc. in Salt Lake City, has developed an immunoassay based on the recombinant Rheumatoid Arthritis IgM-associated Antigen (RAMA) that diagnoses and measures the extent of RA in patients. The test gives a quantitative determination of RA-associated antibodies in patient sera that react with the antigen. The presence of RA-associated antibodies is an objective indicator of RA and its severity.
The technology for this assay is patented broadly. The third of three U.S. patents issued today. Patent No. 5,723,314 is a continuation in part of U.S. Patent No. 5,395,753 that issued in 1995. Another U.S. patent, No. 5,585,464, issued in December 1996. An International Patent Application is pending (published in September 1994 as WO 94/19374).
RA is an autoimmune disease of unknown origin characterized by chronic, symmetric inflammation of joints, especially in the hands. The disease affects more than two million people in the United States alone. Physicians traditionally diagnose RA by subjective observation and anecdotal information from patients. They also must rule out a variety of diseases that mimic RA. Definitive diagnosis of RA may take months or even years because physicians have had no reliable way to diagnose RA.
The most widely employed test for RA is that for serum rheumatoid factor (Rf), an autoantibody that binds to a portion of immunoglobulin G, the principal immunoglobulin in human serum. Although Rf is present frequently in RA, it occurs also in many other conditions besides RA. As a diagnostic, the Rf test generally lacks adequate specificity for RA. Other assays employed to detect RA are even less RA-specific that the Rf test.
The new patent contains data from a RAMA-based assay of sera from 20 healthy persons, 60 patients with clinical symptoms of RA (35 Rf positive and 25 Rf negative) and 20 patients who tested positive for a systemic lupus erythematosus (SLE) marker.
The assay diagnosed RA in all Rf-positive patients but one and nearly half the Rf-negative patients. These results suggest the RAMA assay could diagnose about 85 percent of rheumatoid arthritis cases reliably.
Once developed into a commercial test, the RAMA assay could replace the current, less-specific Rf assay.
For licensing information contact Thomas C. Goodman, Ph.D., M.B.A., RCT Life Sciences Associate, (520) 748-4400, (520) 748-0025 fax.
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Research Corporation Technologies (http://www.rctech.com) is an independent technology management company that commercializes technologies from universities and research institutions throughout North America. Commercialization vehicles include licensing, partnerships, joint ventures and seed investments in early stage technology development.
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