Health Discovery Corporation ("HDC") (OTCBB: HDVY) today 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%.
In the United States alone there are over 1 million prostate cancer tissue biopsy procedures performed annually. Approximately 25% of these tissue biopsies are reported "positive" indicating the presence of prostate cancer. The other 75% of prostate cancer tissue biopsies are reported as "negative" for the presence of cancer. However, one–third of the men with prostate cancer tissue biopsies that are reported as "negative" for prostate cancer (roughly 25%) actually do have prostate cancer that was missed by the first biopsy (False Negative). These men actually have prostate cancer that was missed by the initial tissue biopsy for a variety of reasons. Health Discovery Corporation´s prostate cancer molecular diagnostic test is a genomics based test discovered using HDC´s patented SVM and SVM–RFE pattern recognition technology. This prostate cancer test is based on a unique and patent protected combination of 4 genes that accurately identify the presence of Grade 3 or higher (clinically significant cancer) prostate cancer cells, as well as normal and BPH cells in prostate tissue.
"We are absolutely elated with the results of these additional Phase II clinical trial results and now look forward to having this new prostate cancer test commercially available and generating revenue for HDC in Q3 of 2008," stated Stephen D. Barnhill, M.D., Chairman and CEO of Health Discovery Corporation. "The successful development, validation and commercialization of this new molecular diagnostic test for prostate cancer proves that HDC, by combining our patented SVM and SVM–RFE technology and our expert Scientific Team, has the ability to produce new molecular diagnostic tests which are the future of diagnostic medicine. Our patent protected discovery method allows us to develop molecular diagnostic tests that are free of outside intellectual property rights and thereby allows HDC to fully patent protect our molecular diagnostic gene signatures. Using the same expertise of our Scientific Team and the HDC patented technology, we are currently developing additional new molecular diagnostic tests in a variety of other cancers some of which we hope will be commercially available in Q4 of 2008."
Dr. Barnhill continued, "We are looking forward to having HDC´s new gene–based prostate cancer test commercialized like similar molecular diagnostic tests based on unique gene expression profiles such as OncotypeDX from Genomic Health, Inc. (NasdaqGM: GHDX) and MammaPrint from Agendia."
"The excellent results seen in both the Phase I and Phase II double blinded clinical trials validate the scientific accuracy and robustness of the HDC gene–based molecular diagnostic test for prostate cancer," stated Dr. Herbert Fritsche, Professor of Laboratory Medicine and Chief of the Clinical Chemistry Section at The University of Texas, M.D. Anderson Cancer Center in Houston, Texas. "Health Discovery Corporation´s proven ability to develop state–of–the–art molecular diagnostic tests for cancer brings the promise of personalized medicine to reality."
Savannah–based Health Discovery Corporation (OTCBB: HDVY) is uniquely positioned in the field of pattern recognition technology. Through the application of its patent protected technology, HDC is a biology–oriented biomarker discovery company providing all aspects of First–Phase Biomarker Discovery(sm). The Company´s SVM and FGM pattern recognition tools have significant application potential in other sizable commercial markets such as radiology, financial markets, Internet search and spam, homeland security, and other areas where analysis of large volumes of complex data is required.
This news release contains "forward–looking statements" within the meaning of Section 27a of the Securities Acts of 1933 and Section 21E of the Securities Exchange Act of 1934. Although the management team of HDC believes that the expectations reflected in such forward–looking statements are reasonable, they can give no assurance that such expectations will prove correct.