MedClone Inc. announced last week that it will begincommercial development of its ELISA format confirmatory testfor diagnosing rheumatoid arthritis (RA). It plans to submit a510K for marketing clearance with FDA by the end of the year.
Privately held MedClone of Los Angeles, has the exclusiveworldwide license on this assay from the University ofCalifornia, which has applied for various patents worldwide onthe technology. The assay itself was developed by UCLA'sRichard Weisbart, chief of rheumatology in the San FernandoValley program.
MedClone's assay measures rheumatoid factors from patientsera that specifically cross-link shared epitopes on both humanand sheep IgG.
MedClone claims that this is a more specific test than the onesnow available because it "effectively filters out those moietiesnot associated with RA, such as allo-antigens and the denaturedimmunoglobulins associated with the presence of infectiousdiseases, other connective tissue diseases and age-relatednecrotic activity."
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