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.