US Market Estimates

• 41 million men - over the age of 50
  
• 30 million men - aged 50 - 70
  
• 11 million men - annual number tested for PSA
  
• 1.5 million men - referred for biopsy annually
  
• 300,00 men - cancers detected annually
  
• 30,000 men - annually die of cancer

Clinical Background
This year nearly 30,000 men will die of
prostate cancer in the US. It is well acknowledged that many of these deaths could be prevented if screening and early detection methods could be instituted that provide reasonable indication as to who is at risk for cancer. Unfortunately, the only test in clinical use with FDA approval is the serum prostate specific antigen (PSA) test or derivative PSA tests. While PSA testing has had a significant impact in reducing cancer deaths, its lack of accuracy has stifled efforts to make further progress in reducing death from this treatable disease.