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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