Autoantibodies as serum biomarkers for prostate cancer diagnosis and prognosis

Prostate cancer is the most commonly diagnosed cancer and second leading cause of cancer-related death in males. A highly sensitive, selective, noninvasive screening assay is needed to diagnose prostate cancer and to monitor effectiveness of treatment or recurrence. We are developing a diagnostic assay based on autoantibodies as serological markers for early detection and monitoring of prostate cancer. Key to this methodology is that the immune system creates a huge amplification of signal through the development of antibodies to cancer-associated antigens present in serum with a 10e7-9 increase in measurable signal caused by the production of antibodies by B cells. In Phase I we identified a panel of candidate autoantibodies present at high frequency in prostate cancer patient sera. In Phase II, we will narrow this panel to prostate-cancer specific autoantibody-reactive antigens and format them into an ELISA and test against a large number of patients at all stages of prostate cancer to develop a test with better sensitivity (at least 95%) and specificity (false positives less than 5%) than the standard PSA test. This assay will be compatible with commercial diagnostic formats, and will be ready for large-scale clinical testing as part of the FDA 510K marketability approval process.