Health Discovery Corporation ("HDC")
(OTCBB: HDVY) today announced the successful clinical trial results for
HDC´s new molecular diagnostic test for
prostate cancer licensed exclusively to Clarient (Nasdaq:CLRT), in which
HDC will receive a 30 percent royalty based on reimbursements received
by Clarient from third parties.
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) 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) 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.
