Topic: Biomarkers

John Cucci, an executive at Acupath Laboratories, Inc., introduces the URO17TM antibody, a promising adjunct to cytology for bladder cancer diagnosis. Mr. Cucci explains that while cytology is the standard technique used in diagnosing bladder cancer and has a high positive predictive value, its sensitivity is low. URO17TM detects the expression of keratin-17, a protein strongly associated with bladder cancer, and has greater than 95% sensitivity and specificity. Mr. Cucci goes over the promising early results for URO17TM, as discussed in several papers, and notes that it has been given an expedited clinical trial process by the FDA. He also looks at its potential clinical utilization, both as a screening tool for hematuria patients and as a long-term monitoring tool for bladder cancer patients after they complete therapy. He emphasizes that URO17TM can cheaply and effectively provide additional and reliable information for the pathologist and urologist to more appropriately rule in or out additional diagnostic work-up in patients. Mr. Cucci concludes by presenting a graphic of the URO17TM diagnosis categories and risk meter.