Clarient and Health Discovery Corporation Announce Results from Prostate Profile Clinical Validation Studies

ALISO VIEJO, Calif. & SAVANNAH, Ga.--(BUSINESS WIRE)--Clarient, Inc. (Nasdaq: CLRT), a premier anatomic pathology and molecular testing services resource for pathologists, oncologists, and the pharmaceutical industry, and Health Discovery Corporation (HDC) (OTCBB: HDVY) a leader in support vector machine (SVM) based molecular diagnostic and prognostic test development, today announced that the companies have completed the three-phased, double-blind clinical validation studies for their new gene-based molecular diagnostic test for prostate cancer.

Results from Phase I, Phase II and Phase III double-blinded clinical validation studies on prostate tissues obtained from multiple sites, including those tested in collaboration with MD Anderson Cancer Center and Clarient, demonstrated an excellent 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, the new gene-based molecular diagnostic test 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 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,” stated Ron Andrews, Clarient’s Chief Executive Officer. “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.”

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). Clarient believes this new genomics-based molecular diagnostic test may be able to detect molecular changes in the tissue adjacent to prostate cancer, assisting physicians in identifying which men in the “False Negative” group could have prostate cancer.

The Clarient Insight™ Dx Prostate Cancer Profile was discovered by HDC using their patented SVM and SVM-RFE pattern recognition technology, and is based on a unique and patent protected combination of four genes that are believed to accurately identify the presence of Grade 3 or higher (clinically significant cancer) prostate cancer cells, as well as normal and BPH cells in prostate tissue.

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, said, “The positive results seen in Phase I, Phase II, and Phase III double-blinded clinical studies appear to validate the scientific accuracy of this gene-based molecular diagnostic test for prostate cancer. Physicians who are diagnosing and treating prostate cancer patients should be greatly assisted by the additional information that this new prostate cancer test may add to their decision making process.”

Stephen D. Barnhill, M.D., Chairman and CEO of Health Discovery Corporation, stated, “We are very pleased with the final results of the double-blinded clinical trials and are looking forward to entering the commercialization phase of our prostate cancer test. The successful development and validation of this new molecular diagnostic test for prostate cancer proves that HDC, by combining its patented SVM and SVM-RFE technology with its expert Scientific Team, has the ability to produce new molecular diagnostic and prognostic tests that are contributing to the future of personalized medicine.”

The companies plan to immediately begin presenting papers for publication and presentations at upcoming meetings as they initiate the technical marketing phase of commercialization. The companies also believe that, once the required internal documentation is completed, the current validation studies will be adequate to establish the test as a Lab-Developed Test under current guidelines. Also, the companies intend to initiate a study utilizing urine samples to potentially expand the indication of this test to a screening application which could significantly expand the current market opportunity.

About Clarient

Clarient combines innovative diagnostic technologies with world class expertise to assess and characterize cancer. Clarient’s mission is to become the leader in cancer diagnostics by dedicating itself to collaborative relationships with the healthcare community to translate cancer discovery and research into better patient care. 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 diagnostic services available both onsite and over the web. The Company is also developing new, proprietary “companion” diagnostic markers for therapeutics in breast, prostate, lung and colon cancers, and leukemia/lymphoma. Clarient is a Safeguard Scientifics, Inc. 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.

About Safeguard

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.