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Monoclonal antibody (MAb)B72.3 has been used to detect the presence of TAG-72 in the serum of carcinoma patients. We have developed new anti-TAG-72 MAbs and have selected one of these, CC49, as the "catcher" MAb with 125I-B72.3 as the detecting antibody in a double-determinant immunoradiometric assay. This combination enabled the development of a sequential assay (designated CA 72-4) that showed optimal quantitative properties as demonstrated by such parameters as linear dose-response, high re-producibility, and lack of serum-matrix and "hook-back" effects. Only 3.5% of 744 normal sera and 6.7% of 134 sera from patients with benign gastrointestinal diseases had TAG-72 levels greater than 6 U/ml. Approximately 40% of 303 patients with gastrointestinal malignancies had serum TAG-72 levels of greater than 6 U/ml (55% of the patients with advanced disease). Thirty-six percent of patients with adenocarcinomas of the lung and 24% of patients with ovarian cancer (53% stage IV patients) also had elevated serum TAG-72 levels. A poor correlation was found between the carcinoembryonic antigen (CEA) and TAG-72 values of sera obtained from gastric cancer patients. Thirty-four percent of CEA negative cases were scored positive in the CA 72-4 assay, suggesting the complementarity of the CA 72-4 assay to CEA assays in the analysis of sera from patients with certain malignancies.

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