Bladder cancer is a highly prevalent and lethal malignancy and is one of the most expensive cancers from diagnosis to death of the patients. Patients presenting with symptoms are diagnosed with invasive cystoscopies, of which the vast majority are negative for the disease. Non-muscle invasive bladder cancer has a 70% rate of recurrence, making it a considerable strain to the healthcare system, due to the need for repeated monitoring by cystoscopies. There is thus a great need for good non-invasive biomarkers that can provide early detection and efficient disease monitoring, reducing the need for cytoscopies.
Analysis of urinary samples from bladder cancer patients, healthy donors, renal and prostate cancer patients demonstrate that the panel can identify bladder cancer patients with a high level of sensitivity and specificity which is superior to the best available methods. The analysis of the methylation level of the genes may be performed in an automated manner by methylation-sensitive PCR.
Thus the clinical results support development of a non-invasive test that will allow early diagnosis and subsequent monitoring of disease, reducing the need for invasive cytoscopies.
The technology has been developed based on one cohort of Norwegian. We plan to provide further clinical validation, both on biobanked and prospectively collected clinical samples, for both the pre-diagnostic and monitoring setting.
A patent application (WO 2012052844A1) is pending in US, EU and CA. The patent application claims diagnostic, prognostic and predictive uses of the technology.