Our Prostate Cancer Program
 
In prostate cancer screening currently relies on PSA (Prostate Specific Antigen) which is not cancer-specific, leading to many unnecessary prostate biopsies. Further, prostate cancer is often a slowly progressing form of cancer, there is a lot of uncertainty in how to manage men with diagnosed cancer. There is a high medical need for better tools in early detection, diagnosis and risk assessment of clinically relevant prostate cancer that warrants immediate therapy.

To this end, we have progressed our prognostic prostate cancer test for biochemical recurrence risk assessment after prostatectomy that is based on our proprietary biomarker ^mPITX2 through clinical validation. We are in the process of making this test available first within an early access program with selected clinical centers in Europe and eventually as an IVD test through commercialization partners. Together with our partner TIB Molbiol, we introduced a research product to analyze methylation of the GSTP1 gene in biopsy tissue in Europe in early 2008. First clinical centers currently make use of this product to establish and independently validate laboratory-developed tests to improve the diagnosis of prostate cancer on biopsies. Further, we licensed this biomarker for similar applications to Quest Diagnostics and Predictive Biosciences in the United States.

After having demonstrated our biomarkers performance in urine-based screening for prostate cancer, similar to PSA blood testing. We may in the midterm, invest further research into the question of how to combine diagnostic and prognostic information into a screening test to provide benefits beyond the standard currently set by PSA.

The products by Epigenomics or its partners mentioned on this page are 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.