CLEVELAND -- A new prostate screening test developed by AnalizaDx, Inc., a Cleveland-based biotech company, and studied by researchers at the Seidman Cancer Center at University Hospitals Case Medical Center along with colleagues at the Cleveland Clinic, the Veterans Administration Boston Healthcare and the National Cancer Institute, may prove to be a promising new tool in the diagnosis of prostate cancer.
The study published in the September issue of Urology found that this new screening test, the PSA/SIA assay, may be more sensitive in detecting prostate cancer than traditional screening methods.
"This has the potential to be a major advance in the development of more accurate tests for prostate cancer diagnosis," says Mark Stovsky, MD, Principal Investigator and lead author of the study, urologist at UH Case Medical Center and Associate Professor of Urology at Case Western Reserve University School of Medicine.
Prostate cancer is the most common cancer in men but traditional screening is not very accurate. Recently a government task force recommended against testing healthy men annually because it may lead to unnecessary treatment.
This test provides a new way to determine which PSA molecule is cancerous and which isn't.
The PSA/SIA test was also found to have relatively high specificity (low false positive) results compared to the traditional serum PSA test.
The initial study, which followed 222 men, found that the new screening method had 100% sensitivity (no false negative results) and 80.3% specificity (low false positive results).
The study data was collected at three clinical sites -- UH Case Medical Center, VA Boston and Cleveland Clinic, and was analyzed at the National Cancer Institute.
"This new assay is a complete departure from how the scientific community has looked at biomarkers for cancer," says Arnon Chait, CEO of AnalizaDx, Inc.
"Instead of just measuring levels of proteins, we are exploring changes in structure which are associated with cancer. This new method of diagnosing cancer truly has significant potential for other types of cancer as well."
The technology will be tested in further clinical research studies to determine its accuracy as well as its ability to predict cancer grade/aggressiveness and the response to curative intent therapies. \