Health Discovery Corporation today announced that the RT-PCR assay for the four genes comprising HDC's recently commercialized gene-based molecular diagnostic test for prostate cancer, which is currently available at Clarient Inc.'s Clinical Laboratory, can be successfully used in urine samples for gene testing.
The study, completed in collaboration with MD Anderson Cancer Center, demonstrated that the gene expression of all four genes comprising the molecular signature for clinically significant prostate cancer could be detected in urine samples spiked with as few as 50 prostate cancer cells.
These are the same genes in HDC's recently commercialized molecular diagnostic test for prostate cancer. Results from Phase I, Phase II and Phase III double-blinded clinical validation studies completed with prostate tissues obtained from multiple sites, including those tested in collaboration with MD Anderson Cancer Center demonstrated a very high success rate for identifying the presence of Grade 3 or higher prostate cancer cells (clinically significant cancer), as well as, normal and BPH (benign prostatic hyperplasia) cells. To date, 322 prostate tissues have been tested. The combined results of the recently completed double-blinded clinical validation studies demonstrated that the new gene-based molecular diagnostic test for prostate cancer achieved a Sensitivity of 90% for correctly identifying the presence of Grade 3 or higher prostate cancer cells, and a Specificity of 97% for correctly identifying non-cancer cells (normal and BPH), representing an overall test accuracy of 93%.
"We are very pleased that the results of our clinical trial demonstrated that the four genes comprising HDC's recently commercialized molecular diagnostic test for prostate cancer could indeed be successfully identified in urine," stated Stephen D. Barnhill, M.D., Chairman and CEO of Health Discovery Corporation. "Based on these initial findings, we intend to immediately begin clinical testing to confirm these successful findings in a larger clinical trial. If the results of the larger clinical trial confirm these initial findings in urine, we believe that this could lead to the rapid development of a more accurate screening test for prostate cancer to compete in the PSA market where more than 45 million PSA tests are performed annually worldwide."
Dr. Barnhill continued, "In addition to HDC's recently commercialized molecular diagnostic test for prostate tissue biopsies, this would be HDC's second molecular diagnostic test for prostate cancer which could be used for screening all patients at risk for prostate cancer."
The molecular diagnostics market is the fastest-growing segment of the in vitro diagnostics industry. In little more than a decade, the clinical market for molecular diagnostic products has increased from less than $50 million to over $1 billion. The worldwide in vitro serum cancer diagnostic market is US$800 million and growing at a rate of 7% per year. Therefore, the prospect of identifying novel markers for early detection of various cancer types will have a significant impact on the diagnostic market. Prostate cancer is the second leading cause of cancer mortality among men in the United States behind lung cancer. According to the American Cancer Society, 232,000 new cases of prostate cancer will be diagnosed in the U.S. and an estimated 30,350 deaths will occur from this disease. Furthermore, more than 350,000 patients worldwide are diagnosed with prostate cancer every year.