New prostate cancer molecular test ready for commercialization

27 August 2008

US company Health Discovery Corporation (OTCBB: HDVY) has announced the completion of a Phase III double-blind clinical trial of a new gene-based molecular diagnostic test for prostate cancer.

The company says the test is ready for commercialization to be used by physicians on their patients at risk of having prostate cancer.

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, MD, Chairman and CEO of Health Discovery Corporation.

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. 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.”

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."

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