Clarient, Inc. (Nasdaq: CLRT), a premier anatomic pathology and molecular testing services resource for pathologists, oncologists, and the pharmaceutical industry, today 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.”

Andrews concluded, “Clarient is focused on delivering high-value content for cancer management through the community pathologist. Clarient has a solid track record of success marketing non-exclusive tests as evidenced by our recent success with KRAS. Clarient continues to study additional markers that may influence a cancer pathway, and looks forward to introducing new tests that will help our client base further deliver the promise of personalized medicine.”

“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 labeled 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.”

Prostate Profile Clinical Validation Studies Results

The final results from the combined clinical validation studies were previously announced in August 2008. The studies were performed on prostate tissues obtained from multiple sites, including those tested in collaboration with a prestigious cancer center and Clarient demonstrated the ability to accurately identify the presence of Grade 3 or higher prostate cancer cells (clinically significant cancer). 71 out of a total of 322 prostate tissues tested, were validated at Clarient, and the results provide evidence of the gene set’s ability to help confirm the presence of high grade prostate cancer at a molecular level. The Prostate Gene Expression Profile uses expression values from four genes variably expressed in cancer cells as inputs to a mathematical classifier. In the clinical validation study, the new gene-based molecular diagnostic test achieved a sensitivity of 90% for correctly identifying the presence of Grade 3 or higher prostate cancer, and a specificity of 97% for correctly identifying non-cancer tissue (normal and BPH), representing an overall test accuracy of 93%.

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 actually do have prostate cancer that was missed by the first biopsy (False Negative).