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CLEVELAND – (BUSINESS WIRE) – Cleveland Diagnostics, Inc., a clinical-stage biotechnology company focused on the development of next-generation diagnostic tests for the early detection of cancers, today announced the publication of a health economic analysis in Urology practice. The publication demonstrates the cost-effectiveness and economic utility of the Cleveland Diagnostics IsoPSA test for the detection of clinically significant prostate cancer.
The published review predicted cost savings from the IsoPSA test based on previous clinical evidence of its effectiveness over a standard care workup to guide the need for repeat prostate biopsy. The current study evaluated the cost-effectiveness of IsoPSA for the detection of a high-grade, clinically exploitable disease that can lead to downstream treatment of primary cancer. Model inputs included established determinants of IsoPSA diagnostic accuracy (i.e., AUC, sensitivity, specificity, and predictive value), the cost of IsoPSA, and conservative estimates of the costs associated with assessments and treatment. conventional diagnosis of prostate cancer. Among the patients requiring repeat biopsies, the econometric model indicated that the use of IsoPSA reduced the number of biopsies required by 34% overall, resulting in significant cost savings for the healthcare system (16% savings compared to the standard treatment arm).
“Previous studies published in the peer-reviewed literature and led by key opinion leaders from leading urological institutions across the country, have demonstrated that IsoPSA has improved diagnostic accuracy and has the potential dramatically reduce unnecessary biopsies compared to clinical decision making using standard PSA testing. This rigorous analysis of health outcomes now confirms that IsoPSA has the potential to generate substantial savings for payers, including private and government health plans, ”said Arnon Chait, Ph.D., CEO of Cleveland Diagnostics. “Based on this new information, we believe that IsoPSA has tremendous potential to change the paradigm for the detection and management of prostate cancer.
“Our study demonstrates significant cost savings associated with reducing the volume of biopsies among this cohort of patients, ”said Yair Lotan, MD, study lead author and professor of urology, head of urologic oncology, and Distinguished Jane and John Justin Chair in Urology, in honor of Claus G. Roehrborn, MD at UT Southwestern Medical Center. “We have been studying IsoPSA alongside Cleveland Diagnostics for many years, and hope that IsoPSA will now reduce the number of biopsies needed in actual clinical practice in previously negative biopsy men with a continuing suspicion of cancer.
“We are pleased to see that the overall diagnostic accuracy of IsoPSA should translate into significant savings for health plans, ”added Bob Rochelle, Commercial Director of Cleveland Diagnostics and co-author of the study. “Reducing the number of unnecessary biopsies will not only help reduce the costs associated with painful and invasive biopsy procedures, but also make more efficient use of available biopsy capacity, focusing more of the biopsies performed on the patients who have the most. need, thereby improving the safety and effectiveness of early detection of prostate cancer while achieving substantial savings for patients and payers. ”
It is estimated that one in 9 men will develop prostate cancer in their lifetime. Results from previous studies evaluating over 1000 patients have shown that IsoPSA can reduce unnecessary biopsies by 47% overall, saving men from unnecessary invasive and costly procedures that can sometimes lead to serious and long-lasting side effects. .
About Cleveland Diagnostics, Inc.
Cleveland Diagnostics, Inc., is a commercial stage diagnostic company that develops highly efficient, user-friendly and affordable diagnostic tests using proprietary technology to improve cancer diagnosis. Its Solvent Interaction Analysis ™ (SIA) technology studies protein biomarkers at the structural level (as opposed to the overall concentration of biomarkers in the blood), providing better and more direct information regarding the origin of protein biomarkers at the cellular level, thereby improving the specificity of the underlying test. disease process. Its portfolio of non-invasive cancer diagnostics will span from prostate cancer to breast cancer and lung cancer, infectious diseases and certain neurological diseases, such as Alzheimer’s disease. Visit us at ClevelandDx.com and IsoPSA.com.
Dr Yair Lotan is a consultant and advisor to Cleveland Diagnostics.
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