Prostate cancer is the most commonly diagnosed malignancy and the second leading cause of cancer deaths among men. Current detection methods are based on the detection of prostate specific antigen (PSA). This valuable marker allows physicians to diagnose benign prostate hyperplasia (BPH) and prostate adenocarcinoma. The current PSA test does not discriminate between cancerous and benign conditions. Additional, more specific testing using invasive biopsy methods must be performed to confirm histological presence of cancer. In Phase I, by applying MPD to the polymerase chain reaction, we will develop the first quantitative assay for diagnosis of metastatic prostate cancer. The presence of mRNA transcripts encoding the newly discovered prostate specific membrane antigen (PSMA) is the most statistically reliable marker of metastatic disease. Our MPD enhanced quantitative RT-PCR (qRT- PCR) assay will detect a few PSMA mRNA transcripts providing robust, reliable detection of metastasis. Because gel electrophoresis is not acceptable for commercially viable diagnostic assays, the final detection step will be adapted to a magnetic bead capture format compatible with existing MPD instruments. During Phase II our MPD enhanced PsMA qRT-PCR method will be adapted to a direct detection method (i.e., no amplification) in a low cost, high throughput microplate format.
BioTraces is developing a family of diagnostic assays with improved sensitivity and specificity for early detection and monitoring of prostate cancer. Levels of quantitation orders of magnitude lower than currently available for prostate cancer markers is possible with MPD, a proprietary quantitative radioanalytic system developed by BioTraces. MPD enhanced early detection of prostate cancer will provide the most sensitive, accurate and affordable method of metastasis detection available.