Clarient Launches Gene Expression Test for Prostate Cancer

ALISO VIEJO, Calif.--(BUSINESS WIRE)--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 PATHSiTE^TM 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).

About Clarient

Clarient combines innovative technologies with world class expertise to assess and characterize cancer. Clarient’s mission is to provide the services, resources and critical information to improve the quality and reduce the cost of patient care as well as accelerating the drug development process. The Company’s principal customers include pathologists, oncologists, hospitals and biopharmaceutical companies. The rise of individualized medicine as the new direction in oncology has created the need for a centralized resource providing leading diagnostic technologies such as flow cytometry and molecular testing. Clarient is that resource, having created a state-of-the-art commercial cancer laboratory providing the most advanced oncology testing and drug development services available both onsite and over the web. Clarient is a Safeguard Scientifics partner company. www.clarientinc.com

About Health Discovery Corporation

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 leader in SVM-based molecular diagnostic and prognostic test development in genomics and proteomics, as well as, digital image analysis in pathology and radiology. The Company's patent-protected discovery method allows us to develop molecular diagnostic and prognostic tests that are free of outside intellectual property rights and thereby allows HDC to fully patent protect in-house discovered molecular diagnostic gene signatures. The Company's SVM and FGM pattern recognition tools have significant application potential in other sizable commercial markets such as oil exploration, financial markets, Internet search and spam, homeland security, and other areas where analysis of large volumes of complex data is required. www.healthdiscoverycorp.com

About Safeguard Scientifics

Founded in 1953 and based in Wayne, PA, Safeguard Scientifics, Inc. (NYSE: SFE) provides growth capital for entrepreneurial and innovative technology and life sciences companies. Safeguard targets technology companies in Software as a Service (SaaS) / Internet-based Businesses, Technology-Enabled Services and Vertical Software Solutions, and life sciences companies in Molecular and Point-of-Care Diagnostics, Medical Devices and Specialty Pharmaceuticals with capital requirements between $5 and $50 million. Safeguard participates in expansion financings, corporate spin-outs, management buyouts, recapitalizations, industry consolidations and early-stage financings. www.safeguard.com

Forward-Looking Statements

The statements herein regarding Clarient, Inc. (the “Company”) contain forward-looking statements that involve risks and uncertainty. Future events and the Company’s actual results could differ materially from the results reflected in these forward-looking statements. Factors that might cause such a difference include, but are not limited to: the Company’s ability to market and fund continued development of this new genomics-based diagnostic test for prostate cancer, the Company’s ability to obtain third party payer reimbursement for this test, the efficacy of the test once introduced in the marketplace and the acceptance of this test by physicians and patients, failure to obtain any requisite regulatory clearances or approvals, the Company’s ability to compete with other technologies and with emerging competitors in novel cancer diagnostics and dependence on third parties for collaboration in developing new tests, and risks detailed from time to time in the Company’s SEC reports, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. Recent experience with respect to laboratory services, revenues and results of operations may not be indicative of future results for the reasons set forth above.

The company does not assume any obligation to update any forward-looking statements or other information contained in this document.