A gene-based molecular diagnostic test used to detect prostate cancer has completed the clinical trials process and is ready for commercial use in patients who are at a high risk for the disease. These results were recently released in a press release by Health Discovery Corporation.
Prostate cancer is a common cancer among men in the United States. More than 1 million biopsies for prostate cancer (tissue removed from the prostate for laboratory analysis) are performed in this country each year, with 75% of the biopsies being “negative” (no evidence of prostate cancer). However, one-third of these negative results actually contain cancer that is not accurately identified.
The new test produced by Health Discovery Corporation utilizes gene signatures, a concept used in Oncotype DX® for breast cancer, to identify the presence of prostate cancer. The intent of the test is for use among men who have an initial negative reading on their prostate biopsy.
The latest results leading to the clinical availability of the test revealed that the gene-based test correctly identified 90% of all clinically significant prostate cancers, while correctly identifying 97% of non-prostate cancers; these findings represent an overall accuracy of 93%.
The test will initially be performed at Clarient’s Clinical Laboratory in Aliso Viejo, California, and is available for patients with an increased risk of developing prostate cancer.
Patients who are at an increased risk of developing prostate cancer may wish to speak with their physician regarding their individual risks and benefits of this gene-based molecular test.
Reference: Health Discovery Corporation. New Prostate Cancer Test is Ready for Commercialization Following Successful Completion of Final Clinical Trials [press release]. Available at: http://www.healthdiscoverycorp.com/. Accessed August 2008.