New Prostate Cancer Test is Ready for Commercialization Following Successful Completion of Final Clinical Trials
Health Discovery Corporation’s New Molecular Diagnostic Test for Prostate Cancer Successfully Performs at 90% Sensitivity and 97% Specificity in Double-Blind Clinical Trial
SAVANNAH, Ga.--(BUSINESS WIRE)--Health Discovery Corporation (“HDC”) (OTCBB: HDVY) today announced that HDC’s 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%.
“We are very pleased with the final results of the double-blind clinical trial and are excited to have our first revenue producing molecular diagnostic test ready for commercialization,” 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 and prognostic tests which are the future of personalized medicine. Our patent protected discovery method allows us to develop molecular diagnostic and prognostic 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 pleased to have HDC’s new gene-based prostate cancer test enter the market like similar molecular diagnostic tests based on unique gene expression profiles such as OncotypeDX from Genomic Health, Inc. (NasdaqGM:GHDX) and MammaPrint from Agendia.”
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 initial prostate cancer tissue biopsies that are reported as “negative” for prostate cancer (roughly 25% of men at risk of having prostate cancer) 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 that should be performed on the 75% of men (approximately 600,000 men annually in the US alone) with initial biopsies reported as negative to assist physicians in identifying those men who could have prostate cancer that was missed by the first biopsy.
“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,” 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. “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.”
In a Press Release issued yesterday, Ron Andrews, CEO of Clarient stated “We are very impressed with the results from these validation studies, and I applaud the development teams from both Clarient and HDC for their diligent efforts in bringing this new test through the validation phase significantly ahead of schedule. The early results from these studies confirm our belief that this powerful genomics-based test may provide physicians with useful information to ensure that men with prostate cancer get a more accurate diagnosis sooner and minimize the need for unnecessary biopsies.”
HDC plans to immediately begin presenting papers for publication and presentations at upcoming meetings as we initiate the marketing phase of commercialization. Because of the clinical trial success of this prostate cancer test, the company plans to initiate a study utilizing urine samples to potentially expand the indication of this new prostate cancer test to be used as a screening tool, which could significantly expand the current market opportunity to include all men at risk for prostate cancer.
About Health Discovery Corporation
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 leader in SVM-based molecular diagnostic and prognostic test development in genomics and proteomics, as well as, digital image analysis in pathology and radiology. The Company's SVM and FGM pattern recognition tools have significant application potential in other sizable commercial markets such as oil exploration, financial markets, Internet search and spam, homeland security, and other areas where analysis of large volumes of complex data is required. www.healthdiscoverycorp.com
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.
Contacts
Health Discovery Corporation
Stephen D. Barnhill, MD, CEO, 912-443-1987
sbarnhill@healthdiscoverycorp.com
www.healthdiscoverycorp.com
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