Promus maintains an emphasis in the urology market while focused on enhancing the standards of care when it comes to bladder cancer testing. Our test menu is designed to rule-out bladder cancer in patients diagnosed with hematuria. Although cytology and cystoscopy are the standard of care, these methodologies are prone to miss small papillary bladder tumors, satellite lesions as well as carcinoma in situ. Our Bladder Cancer test menu is a series of inexpensive, non-invasive, urine-based pathology testing designed to help rule out the presence of cancer, sparing many patients invasive cystoscopy procedures, and aiding in the identification of high-risk patients requiring further examination.
History & Facts
Bladder cancer is the fourth most common cancer in men and the eight most common cancer in women. Over 170,000 cases are diagnosed every year in the US and EU, with over 50,000 deaths. Worldwide, the incidence of bladder cancer varies substantially, with over 400,000 cases each year, and the highest rates in Europe and North America. Annually in the US, we consider that there are approximately:
More than 90% of bladder cancer patients in the EU and US have urothelial cell carcinoma (UCC), derived from the urothelium or lining of the bladder, most of whom initially present with superficial disease. These UCC’s have a high chance of recurrence (60-80%), requiring extensive and long-term monitoring for progression to more invasive disease. There are an estimated 1 million individuals in the US and EU living with a diagnosis or history of bladder cancer that require this life-long surveillance.
Hematuria is the most common sign of bladder cancer, with 90% of bladder cancer patients presenting with macro or micro hematuria, however only 15-35% of patients with hematuria are diagnosed with bladder cancer. In the US, over 7 million people are diagnosed with hematuria each year. Under today’s standard of care, diagnosis and surveillance of bladder cancer consists of cystoscopy and cytology. A urine sample is obtained for cytopathology review to identify the cause of hematuria and to rule out bladder cancer. While cytopathology yields a high specificity of more than 90%, its sensitivity, at approximately 50%, is quite weak, leaving many patients without a definitive diagnosis and at risk for low grade bladder tumors. When the cause of hematuria remains unclear, patients are referred to a urologist for further evaluation, leading to about 1 million patient referrals each year. Cytopathologic review is often repeated, and if equivocal, a cystoscopy procedure will be performed.