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

Bladder cancer is one of the most common forms of cancer in North AmericaMost oftenbladder cancer presents as superficial diseasewhich is treatable through surgical resectionbut is also associated with recurrence rates of up toThuspatients must be monitored at regular intervals following resection of the tumor to assess for recurrenceThis monitoring is done by cystoscopywhich requires a scope to be inserted into the urethra and into the bladder to visually inspect the bladder walland is associated with significant patient discomfortpoor compliance to the recommended screening scheduleand high screening costs as cystoscopy must be performed by a physicianIndeedthe cost of screening and surgical interventions makes bladder cancer the most expensive cancer to treat on a per patient basisFinallysmall masses are likely to be missed by visual inspectionresulting in sub optimal assessment of recurrenceThe bladder cancer community has recognized the problems with cystoscopy as the primary screening techniqueresulting in a number of attempts to develop urine based assays to more accurately assess the presence of recurrent diseaseThese assays have looked for the presence of cancer cells or specific proteins associated with cancerUnfortunatelymost of these tests lack specificityas they measure processes that may be present in other non cancer conditions such as infection or kidney stone diseaseor lack sensitivityas they measure events that are present only in a subset of bladder cancer patientsusually high grade diseaseAs a resultnone of the urine based tests currently available are recommended by the American Urological Association as a primary screening toolWe 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 patientsThis technique is non invasiveand we estimate that we will be able to detect moreof all bladder cancer patientsgiving us high sensitivity to detect recurrent diseaseincluding patients with low grade disease who are missed by current screening techniquesWe have performed preliminary tests on patient samples and accurately detected tumors in greater thanof such patientsWe have also performed testing in normal controlsand none have tested positive for the presence of cancerThuswe believe that the test will also have high specificityOur current proposal aims to build upon our preliminary data by expanding the panel of biomarkers that we assay for even greater coverageand to investigate technical enhancements to improve the sensitivityThis 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 techniquesThusthe successful development of our assay will improve patient outcomes while reducing the cost burden on the health care system