Gene-Based Molecular Diagnostic Prostate Cancer Test Validated

A new gene-based molecular diagnostic test for prostate cancer has been validated and is ready to be commercialized for use by physicians on their patients at risk of having prostate cancer.

The combined results of recently completed double-blinded clinical validation studies demonstrated that the new gene-based molecular diagnostic test for prostate cancer 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 benign prostatic hyperplasia), representing an overall test accuracy of 93%.

The test was developed by the Health Discovery Corporation (HDC; Savannah, GA, USA) and it will be performed at Clarient's Clinical Laboratory (Aliso Viejo, CA, USA). HDC will receive 30% royalty on each test performed. The genomics based-test should be performed on the 75% of men (approximately 600,000 men annually in the US alone) with initial biopsies reported as negative, to assist physicians in identifying those men who could have prostate cancer that was missed by the first biopsy.

Stephen D. Barnhill, M.D., chairman and CEO of HDC commented, ``The successful development, validation and commercialization of this new molecular diagnostic test for prostate cancer proves that HDC, by combining our patented [support vector machine] SVM and [support vector machine-recursive feature elimination] 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. Our 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 our molecular diagnostic gene signatures. Using the same expertise of our scientific team and the HDC patented technology, we are currently developing additional new molecular diagnostic tests in a variety of other cancers.”

Related Links:
Health Discovery Corporation
Clarient's Clinical Laboratory