Health Discovery’s new gene-based molecular diagnostic test for prostate cancer has successfully completed its Phase III double-blind clinical trial and is now ready for commercialization. The new prostate cancer test will be performed at Clarient’s Clinical Laboratory in Aliso Viejo, California, and will be used by physicians on patients at risk for prostate cancer.
According to the report, in the United States alone there are over 1 million prostate cancer tissue biopsy procedures performed annually, of which 75% are reported as “negative”. However, one-third of the men with negative reports actually do have prostate cancer; a fact that is often missed on the first biopsy. This is where the company is hoping the new test will prove beneficial, because Health Discovery’s prostate cancer molecular diagnostic test is a genomics-based test that more accurately targets prostate cancer and helps physicians determine a course of treatment. HDC will receive a 30% royalty on each test performed.
Stephen D. Barnhill, M.D., Chairman and CEO of Health Discovery Corporation, stated, “We are very pleased with the final results of the double-blind clinical trial and are excited to have our first revenue producing molecular diagnostic test ready for commercialization. The successful development, validation and commercialization of this new molecular diagnostic test for prostate cancer proves that HDC, by combining our patented SVM and SVM-RFE technology and our expert Scientific Team, has the ability to produce new molecular diagnostic and prognostic tests which are the future of personalized medicine.”
Commenting on behalf of Clarinet yesterday, CEO, Ron Andrews stated “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. 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.”
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