Globally approximately 600,000 men are be diagnosed with prostate cancer each year. In Europe and the United states there are approximately 45 million tests performed each year to diagnose prostate cancer, despite the well-known limitations of the current analysis.
Currently prostate cancer is often initially indicated using the prostate-specific antigen (PSA) assay. However this is very non-specific and ~70% of the positive results are false. Patients presenting with elevated PSA levels visit a urology clinic where they undergo a Digital Rectal Examination (DRE), followed by a Trans-Rectal Ultra-Sound (TRUS), biopsy. These tests may be further complemented by template mapping and MRI scanning where available. Taken together the output from the above tests provides the consultant with a Prostate Diagnostic Pathway, giving each patient a score which will determine the treatment regimen.
Mcm5 testing could be used in conjunction with the PSA test and DRE to significantly reduce the number of patients being unnecessarily subjected to biopsy, and the additional invasive procedures, whilst providing the physician with more compelling evidence on the presence of a tumour. Given the direct role of MCM proteins in cell replication this test offers the prospect of identifying potentially harmful tumours, as Mcm5 levels may correlate with tumour size and grade. Results from UroSens show that measuring MCM proteins increases specificity to approximately 83% and does not lead to false positive results due to prostate hyperplasia.
The Mcm5 test will reduce the number of unnecessary biopsies and provide a tool for population screening.
Monitoring the effectiveness of therapy
Where organ-confined disease is treated by chemo- or radio-therapy, urinary Mcm5 levels may provide an indication of efficacy of treatment. If tumours are shrinking we would expect Mcm5 levels also to decrease.
An effective screening test for non-symptomatic patients should be accurate, low cost and non-invasive. There is currently little confidence in screening using PSA because, whilst the test is not expensive, it is inaccurate: 70% of men with raised PSA will not have cancer. UroSens’ Mcm5 test has been shown to be significantly more accurate in this area of specificity, and is both non-invasive and cost-effective. There is significant market demand for an accurate screening tool for prostate cancer – this is a major opportunity for UroSens.