New Test for Monitoring Recurrent Bladder Cancer

A cytopathology diagnostic test for the early detection of recurrent bladder cancer uses monoclonal antibodies to detect antigens from tumors. The test allows urologists to monitor patients with previously diagnosed bladder cancer.

Called ImmunoCyt, the test is intended for use by pathologists in conjunction with classic urine cytology and cystoscopy. The immunocytochemistry assay uses three monoclonal antibodies to detect surface cell antigens that are found on low-grade tumors. The antibodies, which are labeled with fluorescent markers, bind to two antigens--a mucin glycoprotein and a form of carcinoembryonic antigen (CEA)--expressed by tumor cells in the bladder. By clarifying ambiguous pathology results such as atypia, dysplasia, and other confusing reports, the test increases the sensitivity of urinary cytology. Clinical studies have shown that ImmunoCyt, when combined with cytology, provides a sensitivity of more than 90% in detecting bladder cancer in the early stages.

ImmunoCyt, which has been cleared by the U.S. Food and Drug Administration (FDA), has been licensed to Dako Corp. (Copenhagen, Denmark) by DiagnoCure, Inc. (Quebec City, Canada). Unlike some malignancies, bladder cancer grows rapidly and has a propensity to recur after treatment. Dako says clinical evidence suggests that frequent surveillance is critical to detect recurrences and prevent serious complications.


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