"At this point in time when the PSA has been shown to be ineffective in identifying clinically significant prostate cancer, Health Discovery Corporation's recent biomarker discovery creating a genomic based test that separates grade 4/5 prostate cancer, the most malignant and clinically significant type of prostate cancer from BPH (benign prostatic hypertrophy) and normal prostate with a very high degree of accuracy is an exciting and outstanding accomplishment"
Dr. Thomas A. Stamey
Professor & Founding Chairman
Department of Urology
Stanford University Medical Center
Health Discovery Corporation new gene-based molecular diagnostic test for prostate cancer has now successfully completed it’s Phase III double-blind clinical trial and is now ready for commercialization to be used by physicians on their patients at risk of having prostate cancer. The new prostate cancer test will be performed at Clarient’s Clinical Laboratory in Aliso Viejo, CA. HDC will receive 30% royalty on each test performed.
Results from Phase I, Phase II and Phase III double-blinded clinical validation studies now 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%.
"The excellent results seen in Phase I, Phase II, and Phase III double-blinded clinical trials validate the scientific accuracy and robustness of the HDC gene-based molecular diagnostic test for prostate cancer. Physicians that are diagnosing and treating prostate cancer patients will be greatly assisted by the additional information that this new prostate cancer test will add to their decision making process."
Dr. Herbert Fritsche
Professor and Chief of Clinical Chemistry
M.D. Anderson Cancer Center
