With these results, it's one heck of a buy at 5 cents.
Press Release Source: Health Discovery Corporation
Health Discovery Corporation Announces Successful Clinical Trial Results for New Molecular Diagnostic Test for Prostate Cancer
Wednesday April 30, 4:16 pm ET
New Prostate Cancer Test Demonstrates Very High Accuracy Rate for Detecting Prostate Cancer
SAVANNAH, Ga.--(BUSINESS WIRE)--Health Discovery Corporation (“HDC”) (OTCBB: HDVY - News) today announced the successful clinical trial results for HDC’s new molecular diagnostic test for prostate cancer licensed exclusively to Clarient (Nasdaq:CLRT - News), in which HDC will receive a 30 percent royalty based on reimbursements received by Clarient from third parties.
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The initial clinical validation study recently 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 (clinically significant cancer) 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 (BPH) tissue, as not having genomic evidence of cancer.
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 combination of 4 genes that accurately identify the presence of Grade 3 or higher (clinically significant cancer) prostate cancer cells in prostate tissue.
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. Assuming the data continues to support these initial findings, it is possible that the product could be made available for clinical use by late Q3 of 2008 under the current CLIA regulations.
“We are thrilled with the results of this clinical trial and look forward to the commercial launch of this new prostate cancer test with Clarient,” stated Stephen D. Barnhill, M.D., Chairman and CEO of Health Discovery Corporation. “The success of this clinical trial also demonstrates that HDC, using our patented SVM and SVM-RFE technology, can develop new molecular diagnostic tests from conception of the idea through clinical discovery and validation of unique genomic signatures that can be commercialized as new molecular diagnostic tests. 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.”
Dr. Barnhill continued “We are looking forward to having HDC’s new prostate cancer test commercialized like similar molecular diagnostic tests based on unique gene expression profiles such as OncotypeDX from Genomic Health, Inc. (NasdaqGM:GHDX - News) and MammaPrint from Agendia.”
“The results of this clinical trial demonstrating genomic evidence of the presence of prostate cancer in prostate cancer tissue with 100% accuracy is a remarkable accomplishment,” 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 ability to develop state-of-the-art molecular diagnostic tests for cancer combined with Clarient’s ability to successfully commercialize these tests can provide a significant benefit to cancer patients and their physicians.”
Savannah-based Health Discovery Corporation (OTCBB: HDVY - News) 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.
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