SBIR-STTR Award

The past decade has seen a great impetus in the search for tumor markers- for the detection and management of cancer. This search has led to the discovery of several other carcinofetal proteins such as variants of carcinoembryonic antigen (CEA) and alpha fetoproteins. The tumor marker, Tennessee Antigen, appears to differ significantly from CEA in molecular weight, mobility in immunoelectrophoresis, carbohydrate residue contents, and most importantly, in antigenicity. The clinical evaluation of the antigen has been documented using a hemagglutination inhibition assay (TennaGen Assay). The statistical evaluation of 7,300 assays has been documented and appears to be very promising in colorectal and lung cancers.The refinement of measurement of levels of Tennessee Antigen using the enzyme immunoassay methodology will increase the marker's use in monitoring clinical courses of treatment. The objective of this project is to use available Tennessee Antigen and antibody in the development of an enzyme immunoassay and to evaluate the sensitivity and value of the marker when using a more sensitive methodology than hemagglutination inhibition. The enzyme immunoassay will allow expansion of the scale of values so that one would have a greater differentiation between a negative range and a positive range compared to the range allowed by the hernagglutination inhibition assay. The readability of the assay by electronic apparatus will be more reliable and consistent among users than the hemagglutination inhibition assay, which relies on visual interpretation.National Cancer Institute

A new tumor-associated antigen, called Tennessee Antigen (TAG), has been isolated from 95% of 154 primary human gastrointestinal tumors. In 208 patients with colorectal carcinoma 81% showed elevated levels of TAG in their sera. Our Phase I studies have resulted in the production of monoclonal antibodies (MoAb) and the development of an enzyme-linked immunoassay (EIA) to measure TAG in serum. In the present proposal, we will continue to produce and characterize MoAB using Western Blotting, immunofluorescence technique and immunohistochemical staining. The specificity, sensitivity and reproducibility of EIA will be studied. A prototype of TAG-EIA kit will be developed. The clinical utility of the TAG-EIA will also be evaluated. The objectives of this project are two-fold: l) Utilization of MoAB to TAG as reagents in pathological examination of cancers, 2) Commercialization of the TAG-EIA for Diagnosis and Management of Solid Cancers.