A HOMOGENEOUS ASSAY FOR MIXED CONNECTIVE TISSUE DISEASE

WE PROPOSE TO DEVELOP A HOMOGENEOUS, LIPOSOME-BASED IMMUNOASSAY FOR ANTINUCLEAR ANTIBODY (ANA) DISEASES. IN THE PHASE I STUDIES, WE WILL DEMONSTRATE THE FEASIBILITY OF THE APPROACH FOR ONLY ONE ANA DISEASE, I.E., THE MIXED CONNECTIVE TISSUE DISEASE. THE MAJOR NUCLEAR ANTIGEN U1-RNP, FOR THIS AUTOIMMUNE DISEASE HAS BEEN CLONED IN BACTERIA WITH A PROPRIETARY TECHNOLOGY. WE WILL INCORPORATE THE CLONED U1-RNP INTO LIPOSOME MEMBRANE TO PREPARE TARGET-SENSITIVE LIPOSOMES (ALSO A PROPRIETARY TECHNOLOGY OF LIPOGEN, INC.). GLUCOSE-6-PHOSPHATE DEHYDROGENASE WILL BE ENTRAPPED AS A REPORTER ENZYME. A HOMOGENEOUS, COLORIMETRIC, INHIBITION ASSAY WILL BE DEVELOPED AS A PROTOTYPE FOR FUTURE DIAGNOSTIC PRODUCTS WHICH WILL INCLUDE OTHER ANA ANTIBODIES.