OTraces Inc., a Maryland based company developing blood tests for the early detection of cancer, announces the successful completion of a blinded validation study for diagnosing men with aggressive prostate cancer. The study was conducted at The Johns Hopkins University School of Medicine (JHU) under the direction of Dr. Kenneth J. Pienta, the Donald S. Coffey Professor of Urology and Professor of Oncology and Pharmacology and Molecular Sciences at JHU.
The study was designed to detect men with aggressive prostate cancer (high Gleason Score) versus healthy men. A high Gleason Score is the standard used to determine which men are at high risk of aggressive prostate cancer and most likely in need of immediate intervention. This is a poorly served patient population where new technologies are most needed.
The study demonstrated 95% sensitivity and 87% specificity resulting in an overall predictive power of 89% in distinguishing aggressive Prostate Cancer from not cancer. This is significantly better than the current PSA screening test for prostate cancer which, in the general population, averages 90% sensitivity (10% false negative rate) and 25% specificity (~75% false positive rate) yielding predictive power of 57%.
OTraces, JHU and Dr. Pienta have entered into a contract to conduct additional test development and validation studies for the OTraces prostate cancer blood test including:
• Intermediate Grade Prostate Cancer --- under-diagnosed in the U.S. due to marginal accuracy and low market penetration of the PSA screening test, and;
• BPH (benign prostatic hyperplasia--not cancer) --- common affliction especially in older males and primary cause of elevated PSA levels (false positives).
The test development and validation process will represent a comprehensive review of prostate cancer detection methods by a major medical center and leading researcher and is an opportunity to compare new technology with the existing standard of care in prostate cancer screening and detection.
About OTraces Inc.
OTraces Inc. has developed an In-Vitro Diagnostic Multivariate Index Assay (IVDMVA) proteomic based test platform for the early detection of cancer with high positive predictive power. OTraces cancer detection system utilizes patented algorithmic methods and other techniques to turn low abundance signaling protein concentration measurements into a highly predictive cancer diagnosis. OTraces has averaged positive predictive power of 90%-plus in over 2,000 tests for detecting multiple cancer tumor types as well as in validation trials for the company’s blood tests for prostate and breast cancer screening. In addition to the JHU validation study, OTraces is now concluding the validation of their breast cancer screening test in the Russian Federation in preparation for approval by the Russian Ministry of Health and commercial launch.
About Johns Hopkins University School of Medicine
Dr. Kenneth J. Pienta is senior staff member at the Johns Hopkins University School of Medicine. He is a twotime American Cancer Society Clinical Research Professor Award recipient. He serves as the Director of Research for the Brady Urological Institute. Opened in January 1915, The Brady Urological Institute was the only one of its kind in the country. It was the number one Urological Institute in the USA for 21 years is a row 1991 – 2011. Dr. Pienta was the Associate Vice President for Research, Health Sciences, for the University of the Michigan 2012-2013 and Director of Precision Medicine for the Michigan Center for Translational Pathology from 2008-2013.
Currently, Dr. Pienta is involved in research to define the tumor microenvironment of prostate cancer metastases, as well as developing new therapies for prostate cancer. Between 1995-2013, Dr. Pienta was the Director of the Prostate Specialized Program of Research Excellence (SPORE) at The University of Michigan. He has a proven, peer-reviewed track record in organizing and administering a translational research program that successfully incorporates bench research, agent development, and clinical application. Dr. Pienta has international expertise in the development of novel chemotherapeutic programs for prostate cancer and has championed the concept that translational research is often best accomplished by multi-disciplinary teams of scientists and clinicians. Under his direction, the success of these endeavors led to the receipt of the 2007 first annual American Association for Cancer Research Team Science Award. He is the author of more than 350 peer-reviewed articles, and been the principal investigator on numerous local and national clinical trials. Throughout his career, Dr. Pienta has effectively mentored more than 40 students, residents, and fellows to successful careers in medicine.
