Health Economics Analysis Release Demonstrates IsoPSA® Significantly Reduces Biopsies and Unnecessary Prostate Cancer Costs


CLEVELAND–(BUSINESS WIRE)–Cleveland Diagnostics, Inc., a clinical-stage biotechnology company focused on developing next-generation diagnostic tests for the early detection of cancers, today announced the release of a health economic analysis in Urology practice. The publication demonstrates the cost-effectiveness and economic utility of Cleveland Diagnostics’ IsoPSA test for the detection of clinically significant prostate cancer.

The published analysis predicted cost savings from the IsoPSA test based on previous clinical evidence of its effectiveness over a standard care workup in guiding the need for a repeat prostate biopsy. The current study evaluated the cost-effectiveness of IsoPSA for detecting high-grade, clinically actionable disease that can lead to downstream treatment of primary cancer. Inputs to the model included established determinants of diagnostic accuracy of IsoPSA (i.e., AUC, sensitivity, specificity, and predictive value), cost of IsoPSA, and conservative estimates of costs associated with diagnostic assessments and conventional treatment for prostate cancer. Among patients scheduled for repeat biopsies, the econometric model indicated that the use of IsoPSA reduced the number of biopsies needed by 34% overall, generating significant savings for the healthcare system (16% savings compared to the standard care arm).

“Previous studies published in the peer-reviewed literature and led by key opinion leaders from preeminent urology institutions across the country, have demonstrated that IsoPSA has improved diagnostic accuracy and has the potential to reduce significantly reduce unnecessary biopsies compared to clinical decision-making using current standard PSA tests.This rigorous analysis of health outcomes now confirms that IsoPSA has the potential to generate substantial savings for payers, including health plans. private and government healthcare,” said Arnon Chait, Ph.D., CEO of Cleveland Diagnostics.Given this new information, we believe that IsoPSA holds considerable potential to change the paradigm of prostate cancer detection and management.

“Our study demonstrates significant cost savings associated with reduced biopsy volume among this cohort of patients,” said Yair Lotan, MD, lead study author and Professor of Urology, Chief of Urologic Oncology and Chairman. distinguished Jane and John Justin. 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 real-life clinical practice in men with a prior negative biopsy with continued suspicion of cancer.

“We are excited to see that the overall diagnostic accuracy of IsoPSA is expected to translate into significant cost savings for health plans,” added Bob Rochelle, Cleveland Diagnostics Chief Commercial Officer and co-author of the study. “Reducing the number of unnecessary biopsies will not only help to reduce the costs associated with painful and invasive biopsy procedures, but also make more efficient use of the available biopsy capacity, focusing more of the biopsies performed on the patients who need it the most. needed, thereby improving the safety and efficiency of early detection of prostate cancer while simultaneously achieving substantial cost savings for patients and payers.

It is estimated that 1 in 9 men will develop prostate cancer during their lifetime. Results from previous studies evaluating over 1,000 patients have shown that IsoPSA can reduce unnecessary biopsies by 47% overall, saving men from unnecessary invasive and expensive procedures that can sometimes lead to serious and long-lasting side effects.

About Cleveland Diagnostics, Inc.

Cleveland Diagnostics, Inc., is a commercial-stage diagnostics company that develops highly effective, laboratory-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 the protein biomarker at the cellular level, thereby improving the specificity of the test to the underlying disease process. Its non-invasive cancer diagnostics portfolio will span from prostate cancer to breast and lung cancer, infectious diseases and certain neurological diseases, such as Alzheimer’s disease. Visit us at and

Dr. Yair Lotan is a consultant and advisor to Cleveland Diagnostics.


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