Clarient and Health Discovery complete validation studies for cancer test

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%.

The Clarient Insight Dx prostate cancer profile was discovered by Health Discovery (HDC) using their patented SVM and SVM-RFE pattern recognition technology, and is based on a 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.

Ron Andrews, Clarient’s CEO, said: “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.”