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Health Discovery Corporation announced the successful phase II clinical trial results for HDC’s new gene-based molecular diagnostic test for prostate cancer licensed exclusively to Clarient (Nasdaq:CLRT), in which HDC will receive a 30 percent royalty on each test performed based on the per test reimbursement received by Clarient. In addition to the commercialization license HDC granted to Clarient, HDC retained the right to also commercialize this molecular diagnostic test for prostate cancer in one or more clinical laboratories that HDC elects to own and/or operate.
Results from both the Phase I and Phase II clinical validation studies now completed at Clarient 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. Combining all of the patients from both Phase I and Phase II clinical trials, the new gene-based molecular diagnostic test achieved a Sensitivity of 91.3% for correctly identifying the presence of Grade 3 or higher prostate cancer cells, a Specificity of 100% for correctly identifying normal prostate cells and a Specificity of 90% for identifying BPH cells representing an overall test accuracy of 93.2%.
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