Clarient launches gene expression test for prostate cancer
15 January 2009
Clarient, Inc. (Nasdaq: CLRT), a premier anatomic pathology and
molecular testing services resource for pathologists, oncologists, and
the pharmaceutical industry, has announced the commercial launch of its
new gene expression test for prostate cancer.
This new test will be available through Clarient’s PATHSiTETM virtual
reporting tool and accessible to the company’s entire pathology network
Clarient’s new test is based on a unique and patent protected
combination of four genes that have been shown to accurately identify
the presence of Grade 3 or higher (clinically significant cancer)
prostate cancer cells in prostate tissue. The association of these four
genes with prostate cancer was discovered by Health Discovery
Corporation (OTCBB: HDVY) using their patented SVM and SVM-RFE pattern
recognition technology.
“Clarient is proud to be a leader in offering the latest in cancer
diagnostic testing, allowing patients to avoid unnecessary toxicities
and treatment delays, while lowering the overall cost of therapy,”
stated Ron Andrews, Clarient's Chief Executive Officer.
“The solid results from our clinical validation study confirm our
belief that this powerful genomics-based test may assist physicians in
the tissue diagnosis of prostate cancer. Working with Health Discovery
Corporation, we have now completed the scientific paper documenting our
validation results and have submitted our work to a respected
international medical journal for peer review and publication which will
be paramount to our marketing efforts.”
Today, the two companies also announced that in order to insure
market uptake of the new prostate cancer test, they will transition to a
non-exclusive agreement to allow for licensing to additional
laboratories. Under the amended agreement, Clarient will retain the
exclusive rights for a prognostic test which may be developed in the
future in conjunction with Health Discovery Corporation.
Commenting on the amended agreement, Andrews stated, “To drive the
utility of new clinical laboratory tests to a standard-of-care position
requires significant marketing efforts and resources. Both Health
Discovery Corporation and Clarient believe that opening up the playing
field for this new prostate cancer test will encourage market uptake
helping to achieve the standard-of-care objective.”
“We are excited to announce that Clarient is now formally launching
HDC’s molecular diagnostic test for prostate cancer,” stated Stephen D.
Barnhill, MD, Chairman and CEO of Health Discovery Corporation. “In
order to achieve a more rapid market uptake, we look forward to having
additional clinical laboratories join Clarient in promoting and
performing this new prostate cancer test in the near future.”
According to Dr Barnhill, “Prostate cancer biopsies are not easy to
interpret. When a biopsy is labelled atypical, which happens in about 5
percent of biopsies at most institutions, it means that a pathologist
sees something that could be cancer, but isn’t sure that it’s definitely
cancer. The other end of this vexing spectrum is that physicians seem
just as likely to over-diagnose cancer. There are many mimickers of
prostate cancer under the microscope, and people not as familiar with
prostate biopsies as specialists in urologic pathology can diagnose
cancer when it’s not actually present.”
In a recently published document, physicians at Johns Hopkins Medical
Center reported that in a six month period they looked at 3,000
patients’ prostate cancer biopsies, almost 700 of which were sent at the
request of either the patient or the urologist. Overall, the expert
uropathologists at Johns Hopkins changed the diagnosis about 35 percent
of the time, and these were not cases in which the pathologist appeared
to have difficulty diagnosing the case.
Dr Barnhill continued, “The high sensitivity and specificity
demonstrated in the validation results of our new prostate cancer test
suggest that this new molecular diagnostic could assist physicians in
more accurately identifying the presence of prostate cancer in patients
with both positive and negative biopsies.”
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