Detection of ovarian cancer by ¹⁹⁸au‐labeled human monoclonal antibody

Background. There is no reliable method for the early diagnosis of ovarian cancer. Radiolabeled monoclonal antibodies have potential to assist in early diagnosis, but they are limited by problems that include antibody specificity, stability, and immunoreactivity, as well as patient reactions to the antibodies used. Methods. Methods were developed to ¹⁹⁸Au‐label a human monoclonal antibody (TC5 antibody), developed against an ovarian cancer cell surface antigen. Antigen binding sites on the TC5 antibody were protected with sepharose 4B affinity chromatography before ¹⁹⁸Au‐labeling. The ¹⁹⁸Au‐labeled TC5 antibody was evaluated with biopsy specimens in a blind study. The immunoreactivity of radiolabeled TC5 antibody also was evaluated in slotblot experiments with extracts of the biopsy specimens. Results. The ¹⁹⁸Au‐labeled TC5 antibody had high binding reaction to all biopsy specimens (six of six) pathologically diagnosed as ovarian cancer (serous and endometrioid adenocarcinoma). The radiolabeled TC5 antibody did not bind to any normal (non‐neoplastic) specimens (zero in ten), with one exception. One “normal” ovary specimen had high binding of radiolabeled TC5 antibody, and metastatic ovarian cancer was diagnosed 4 months later. The TC5 antibody labeled with ¹⁹⁸Au, without protecting antigen‐binding sites, did not bind to any biopsy specimens. Conclusions. The affinity‐labeling method was necessary to protect antigen‐binding sites and preserve the immunoreactivity of the TC5 antibody. The ¹⁹⁸Au‐labeling method may be an ideal technique to evaluate monoclonal antibodies in vitro. The TC5 antibody had high sensitivity and specificity for detecting ovarian cancer. Cancer 1994; 73:878–83.