The initial clinical validation study completed at Clarient from prostate tissues obtained 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 in prostate cancer tissue. The new molecular diagnostic test achieved a sensitivity of 100% meaning that the test correctly identified genomic evidence of prostate cancer cells in every tissue specimen known to be positive for prostate cancer.
The test also demonstrated a very high success rate for correctly identifying those prostate specimens that did not have prostate cancer as being negative for prostate cancer and achieved a specificity of 80% for identifying the non-cancer tissues, which included normal and benign prostatic hypertrophy tissue, as not having genomic evidence of cancer.
Health Discovery Corporation (HDC) and Clarient will now move to phase two of the clinical trial process to increase the number of specimens tested in order to achieve the statistical significance necessary to validate these very successful initial results. Once the next phase of clinical testing is completed, the companies will begin the commercialization process.
Stephen Barnhill, chairman and CEO of HDC, said: “Our patent protected discovery method allows to us to develop molecular diagnostic tests that are free of outside intellectual property rights and thereby allows HDC to fully patent protect our discovery. We are currently duplicating this process to develop new molecular diagnostic tests in a variety of other cancers.”