Clarient, Inc., a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, and Health Discovery Corporation (HDC) 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 per cent 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 programme, 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 endeavours. 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."
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.
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.