SBIR grant application to develop and commercialize a urine based medical diagnostic for the detection of bladder cancer recurrence.

DESCRIPTION provided by applicant Bladder cancer is one of the most common forms of cancer in North America Most often bladder cancer presents as superficial disease which is treatable through surgical resection but is also associated with recurrence rates of up to Thus patients must be monitored at regular intervals following resection of the tumor to assess for recurrence This monitoring is done by cystoscopy which requires a scope to be inserted into the urethra and into the bladder to visually inspect the bladder wall and is associated with significant patient discomfort poor compliance to the recommended screening schedule and high screening costs as cystoscopy must be performed by a physician Indeed the cost of screening and surgical interventions makes bladder cancer the most expensive cancer to treat on a per patient basis Finally small masses are likely to be missed by visual inspection resulting in sub optimal assessment of recurrence The bladder cancer community has recognized the problems with cystoscopy as the primary screening technique resulting in a number of attempts to develop urine based assays to more accurately assess the presence of recurrent disease These assays have looked for the presence of cancer cells or specific proteins associated with cancer Unfortunately most of these tests lack specificity as they measure processes that may be present in other non cancer conditions such as infection or kidney stone disease or lack sensitivity as they measure events that are present only in a subset of bladder cancer patients usually high grade disease As a result none of the urine based tests currently available are recommended by the American Urological Association as a primary screening tool We propose to take advantage of recent technological advances and our understanding of the molecular processes involved in bladder cancer to develop a comprehensive screening panel that assays the urine of patients This technique is non invasive and we estimate that we will be able to detect more of all bladder cancer patients giving us high sensitivity to detect recurrent disease including patients with low grade disease who are missed by current screening techniques We have performed preliminary tests on patient samples and accurately detected tumors in greater than of such patients We have also performed testing in normal controls and none have tested positive for the presence of cancer Thus we believe that the test will also have high specificity Our current proposal aims to build upon our preliminary data by expanding the panel of biomarkers that we assay for even greater coverage and to investigate technical enhancements to improve the sensitivity This approach will lead to the development of a non invasive screening assay that will have excellent sensitivity and specificity at a lower price point than current screening techniques Thus the successful development of our assay will improve patient outcomes while reducing the cost burden on the health care system PUBLIC HEALTH RELEVANCE This research aims to develop a urine based diagnostic assay for the detection of bladder cancer recurrence Bladder cancer has one of the highest rates of recurrence for all cancers and standard of care surveillance by trans urethral cystoscopy is burdensome and costly A urine based assay to detect cancer recurrence has the potential to benefit all bladder cancer patients by providing less invasive options for surveillance improve health care access to rural patients improve screening in patients non compliant with recommending scoping and may reduce the long term costs of surveillance to the health care system