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Abstract

Human tumor associated Thomsen-Friedenreich (TF) antigen is purified from adenocarcinoma conditioned media, adenocarcinoma cell detergent extracts or plural effusion fluid by affinity chromatography using an insolubilized TF-specific monoclonal antibody, MAb 49H.8. The TF antigen is a glycoprotein characterized by a non-cryptic Gal .beta.(1.fwdarw.3) GalNAc epitope, a molecular weight in excess of 1,000,000 daltons, and extractability with perchloric acid, the epitope being sensitive to alkali and periodate but resistant to acid. A heterologous sandwich immunoassay has been developed for human TF antigen using a monoclonal antibody as the catcher and labelled peanut agglutinin as the probe. Since human TF antigen is shed by tumor cells, a positive determination of the TF antigen in a patient sample indicates the presence of cancer. The test can also be used to monitor the course of conventional chemotherapy or radiotherapy by monitoring the amount of TF antigen in a fluid sample from a patient being so treated. Because of the sensitivity of the assay method, cancer can be detected in very early stages by the assay method of the present invention.

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First Claim