Colorectal carcinoma is one of the most prevalent and lethal cancers in the United States. According to the American Cancer Society, there are 130,000 new cases each year. Early diagnosis is difficult and there is no diagnostic test with a high positive predictive value in the early stages of the disease. Development of a test that detects early colorectal carcinoma would significantly reduce morbidity and mortality.Testing the feasibility of a monoclonal-based serum test for a colorectal carcinoma marker is now warranted. Monoclonal antibodies generated against crude extracts of colorectal carcinoma cells or from homogenates of colorectal cell cultures have been produced by a number of different investigators. Some monoclonal antibodies with potential for a rapid test have been developed by Chan's group at M.D. Anderson. Granite Diagnostics proposes to evaluate these antibodies to detect the relevant antigen(s) in urine and/or serum samples and to develop a test for early diagnosis of colorectal carcinoma.Favorable results in Phase I research will lead to Phase II development and testing of a marketable kit.National Cancer Institute (NCI)
