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31-Jul-2007 - New Molecular Diagnostic Test for Prostate Cancer
Clarient and Health Discovery Corporation Initiate Alliance with Licensing Agreement for New Molecular Diagnostic Test for Prostate Cancer
First Proprietary Molecular Diagnostic Test in Clarient's Novel Marker Program July 31, 2007: 06:00 AM EST
ALISO VIEJO, Calif. and SAVANNAH, Ga., July 31 /PRNewswire-FirstCall/ -- Clarient, Inc. , a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, and Health Discovery Corporation today jointly announced an alliance that begins with the commercialization of HDC's new prostate cancer marker. Under the terms of the agreement, Clarient obtained an exclusive license to HDC's prostate cancer marker and plans to immediately initiate the commercialization process for the test. In turn, HDC will receive a 30 percent royalty for all prostate cancer tests performed by Clarient utilizing the HDC marker discovery (based on reimbursements received by Clarient from third parties for such tests). The exclusive agreement provides Clarient with a unique 4-gene test that may enhance the early detection and staging of prostate cancer, thereby helping doctors make better decisions on diagnosing this disease and determining more appropriate, patient specific treatment plans.
The prostate cancer test will be the first molecular test in Clarient's novel marker program, and the larger ongoing relationship between Clarient and HDC could also result in additional diagnostic and prognostic tests developed by HDC and commercialized by Clarient. HDC will lead the research effort through the application of its patent protected SVM technology. Clarient will have a right of first refusal to license and commercialize any subsequent cancer tests resulting from HDC's development endeavors. Clarient anticipates that it will begin validation work on HDC's prostate cancer marker immediately and follow with appropriate clinical studies to support the preliminary findings. Once the clinical studies are completed, Clarient will seek the necessary regulatory approvals and clearances.
"Prostate cancer is one of the leading causes of death for men," said Ron Andrews, President and CEO of Clarient, Inc. "Today, there are more than 100 new therapeutics in various phases of clinical trials aimed at treating the disease. Our agreement with HDC offers Clarient the opportunity to be a larger player in this rapidly expanding diagnostic marketplace."
Andrews continued, "As a result of this agreement, Clarient takes an important step toward further differentiating its service offering and moves the Company closer to its goal of a leadership position in the characterization and assessment of cancer. The right to develop and market HDC's gene set provides Clarient with one of the most advanced tools available to distinguish various grades of prostate cancer. Validating a marker will also allow us to work with therapeutic companies to provide access to valuable information as they select patient cohorts for future clinical trials."
Andrews further stated, "We are very enthusiastic about the growing number of opportunities for our novel marker program. This program will focus on the development of molecular diagnostic tests and capabilities to further clarify the complexity of cancer and is part of our overall strategy to deliver high value information to our community healthcare partners."
"The World Health Organization estimates that prostate cancer in men is expected to increase 40 percent worldwide in the next 25 years," said Stephen D. Barnhill, M.D., HDC's Chairman and CEO. "Current prostate cancer screening sales are estimated to be more than $350 million annually and represent 40 percent of all annual cancer serum biomarker revenues. More than a million men a year undergo biopsies of the prostate. There is tremendous market opportunity here."
Barnhill continued, "This new commercialization partnership with Clarient is a giant step forward for our company. Clarient's specialized expertise in cancer testing and its state-of-the-art anatomic pathology clinical laboratory will provide HDC with the ability to quickly commercialize and make available to doctors and patients our new diagnostic and prognostic marker discoveries. This is just one example of how our two companies can make an impact on a critical area of cancer care, together."
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, Inc. partner company. For more information, visit http://www.clarientinc.com.
About Safeguard
Safeguard Scientifics, Inc. , a holding company, builds value in growth-stage technology and life sciences businesses. Safeguard provides growth capital as well as a range of strategic, operating and management resources to our partner companies. Safeguard participates in growth buyout financings, including corporate spin-outs and management buyouts, expansion financings, industry consolidations and early-stage financings. http://www.safeguard.com
About Health Discovery Corporation
Savannah-based Health Discovery Corporation is uniquely positioned in the field of pattern recognition technology. Through the application of its patent protected technology, HDC is a biology-oriented biomarker discovery company providing all aspects of First-Phase Biomarker Discovery(SM). The Company's SVM and other pattern recognition tools have significant application potential in other sizable commercial markets such as radiology, Internet search and spam, homeland security, financial futures, and other areas where analysis of large volumes of complex data is required.
The statements herein regarding Clarient, Inc. and HDC contain forward- looking statements that involve risks and uncertainty. Future events and Clarient'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: Clarient's ability to validate and/or obtain any necessary regulatory clearances or approvals for the commercialization of HDC's prostate cancer novel marker and any other novel markers that may be developed by HDC or other third parties and licensed to Clarient; Clarient's ability to successfully commercialize novel markers and the acceptance of the relevant laboratory tests in the marketplace; whether Clarient and HDC are able to reach agreement with respect to the licensing terms for future novel makers developed by HDC; Clarient's ability to obtain favorable third party payer reimbursement for laboratory tests; unanticipated expenses or liabilities or other adverse events affecting Clarient's laboratory business; uncertainty of success in identifying and developing new diagnostic tests or novel markers; Clarient'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 Clarient's and HDC'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.
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