Monoclonal antibodies specific for each of the three amylase isoenzymes; salivary, pancreatic and ovarian will permit a more accurate assessment of the cause of hyperamylasemia. Current methods for measuring total amylase activity in serum are inadequate, while those for isozyme analysis are either indirect or time consuming. During Phase II we intend to utilize the anti-salivary specific and anti-pancreatic specific monoclonal antibodies we have generated as the basis for a diagnostic kit which will permit the direct determination of serum amylase levels. In brief, immobilized monoclonal antibody will be used to capture the appropriate amylase isoenzyme. During Phase II this kit will be rigorously tested and compared with the Phadebas IsoAmylase kit which has FDA approval. Elevated serum levels of an ovarian amylase show a good correlation with serous-type ovarian cancer. During Phase II we will generate monoclonal antibodies specific for ovarian amylase. These antibodies will be used to monitor the amylase activity in serum, cyst tissue and/or fluid, and compared with CA125 reactivity of patients having ovarian cancer. We anticipate that these monoclonal antibodies will form the basis for a diagnostic kit which can be used for monitoring recovery from or recurrence of ovarian cancer.
