The objective of our prostate cancer screening test program is to develop a urine-based screening test for men over 50 years of age that is more specific than the currently most widely used PSA ("Prostate Specific Antigen") testing or can be used as a diagnostic follow-on for men with PSA elevated to 2.5 ng/ml or more. PSA as a tumor biomarker has a moderate specificity, i. e. it is also elevated in a number of benign prostate conditions leading to anxiety in patients, repeated PSA testing, a number of unnecessary prostate biopsies in men without prostate cancer and an increase in the costs associated with these follow-up procedures.

In December 2006, in a first study on blood plasma and urine from prostate cancer patients and healthy controls, we demonstrated that our assays allow for the detection of cancers with a sensitivity of up to 74% at a specificity of 96% (i. e. only 4% false positive results in healthy men) using a single biomarker. The study also demonstrated that urine is the most suitable analyte for the detection of prostate cancer based on DNA methylation biomarkers. In September 2007 we confirmed in another study on prospectively collected urine samples the feasibility of a urine-based prostate cancer test. It is our intend to further optimize our biomarker panel with a focus on biomarkers that can distinguish prostate cancer from the non-cancerous prostate conditions. To this end we have identified 61 novel biomarkers that statistically significantly distinguish prostate cancer tissue from BPH tissue. Of these, the 38 most promising were selected for further evaluation in tissue followed by clinical studies in 2008 for the best candidate biomarkers with prospectively collected urine samples and the recently improved assay procedure for our body fluid-based screening tests.

This products is not available for sale in the United States. The analytical and performance characteristics of any product to be eventually sold in the U.S. based on this technology have not been established.