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."