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Nonspecific Cross-Reacting Antigen 50/90 Is Elevated in Patients with Breast, Lung, and Colon Cancer

Molecular Diagnostics Group, Immunodiagnostics Business Unit, Miles Diagnostics, Tarrytown, New York 10591 [W. J. A., I. E. N., K. K. Y.]; Bayer AG, Pharma Research Center, Building 405, Aprather Weg 18a, D5600, Wuppertal, Germany [J. J. E.]; Institute for Molecular Biologicals, Miles Research Center, West Haven, Connecticut 06516 [T. R. B.]; and Department of Laboratory Medicine, The University of Texas M. D. Anderson Hospital, Houston, Texas 77030 [H. Y., H. A. F.]

A total of 22 genes have been identified in the carcinoembryonic antigen (CEA) gene family. The protein products of this family are highly homologous and include CEA, biliary glycoprotein, nonspecific cross-reacting antigen 50/90 (NCA 50/90), NCA 95, and pregnancy-specific ß-glycoprotein. We used a monoclonal antibody with high affinity to develop a specific enzyme-linked immunosorbent assay (ELISA) method for NCA 50/90 in serum and plasma. Our calibrators were based on affinity-purified recombinant protein from a baculovirus expression system. No significant reactivity with purified CEA, recombinant NCA 95, or recombinant biliary glycoprotein was found by Western blot analysis or in the ELISA method. Only 1 of 15 sera from pregnant women (chorionic gonadotropin > 1000 ng/ml) was positive in the NCA 50/90 ELISA, suggesting that this method does not detect pregnancy-specific glycoprotein. A cutoff value of 18 ng/ml was established based on the 95% value of serum and plasma from 147 healthy volunteers. Only 3 of 31 serum and plasma samples from patients with clinically inactive breast cancer were elevated above the cutoff value, but 44% of 136 samples from patients with clinically active breast cancer were positive. NCA 50/90 measurements were elevated in 7 of 25 patients with active breast cancer whose CEA and CA 15-3 values were below cutoff, and NCA 50/90 values do not correlate with CEA in breast cancer. In addition, we found sensitivities of 70, 39, and 42% for lung cancer, colon cancer, and leukemia, respectively. The sensitivity for non-small cell lung cancer was 85%, however, compared to 50% for small cell lung cancer. Serum from leukemia patients showed an overall sensitivity of 43%, but 71% (10 of 14) sera from patients with chronic myelogenous leukemia were positive compared to, for example, chronic lymphocytic leukemia where 0 of 7 sera had NCA 50/90 values above the cutoff. These studies suggest that NCA 50/90 may have clinical utility in the management of patients with a variety of cancers.

¹ To whom requests for reprints should be addressed, at Molecular Diagnostics Group, Miles Diagnostics, 511 Benedict Ave., Tarrytown, NY 10591.

² Current Address: Scicor, Inc., 8211 Scicor Drive, Indianapolis, IN 46206.

Received 9/30/93. Accepted 12/29/93.

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