Diagnostic products for Systemic Lupus Erythematosus (SLE or Lupus)
About 1.5 million Americans have lupus, according to the Lupus Foundation of America with about an equal number in Europe. The frequency of this disease is estimated to be even higher in Asian and African populations. The high incidence of lupus globally is coupled to the lack of a single laboratory test that can accurately and reproducibly diagnose the disease. Unfortunately, attempts to validate autoantibodies as biomarkers for disease activity have been thwarted by the lack of sensitivity and specificity of any single antibody biomarker in patient populations and a lack of cost effective technology for looking at multiple antibodies in multiple patients in parallel.
20/20 is developing its unique layered membrane technology to address this need. A stack of bioaffinity membranes will be used in the analysis of patient samples. Each membrane in the stack is modified so as to capture a specific autoantibody. (An autoantibody has specificity directed against one of one's own idiotypes. Autoantibodies are one of the hallmarks of immune disease). The utility of such 'layered peptide arrays' for the study of autoimmune disease has already been demonstrated; these results are described in a scientific paper to be published in October, 2005.