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Publication of a Health Economic Analysis Demonstrates IsoPSA® Significantly Reduces Unnecessary Prostate Cancer Biopsies and Costs

CLEVELAND--(BUSINESS WIRE)--Cleveland Diagnostics, Inc., a clinical-stage biotechnology company focused on the development of next-generation diagnostic tests for early detection of cancers, announced today the publication 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 projected cost savings of the IsoPSA test based on previous clinical evidence of its effectiveness compared to a standard of care workup to guide the need for a repeat prostate biopsy. The current study assessed the cost effectiveness of IsoPSA for the detection of high-grade, clinically actionable disease that may lead to downstream treatment of a primary cancer. Model inputs included established determinants of IsoPSA diagnostic accuracy (i.e., AUC, sensitivity, specificity, and predictive value), IsoPSA cost, and conservative estimates of costs associated with conventional prostate cancer diagnostic evaluations and treatment. Among patients scheduled for repeat biopsies, the econometric model indicated that the use of IsoPSA reduced the number of biopsies required by 34% overall, generating significant cost savings to 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 pre-eminent urology institutions across the country, have demonstrated that IsoPSA has improved diagnostic accuracy and has the potential to dramatically reduce unnecessary biopsies compared to clinical decision making using current standard PSA tests. This rigorous health outcomes analysis now confirms that IsoPSA has the potential to generate substantial cost savings to payers, including private and government health plans,” said Arnon Chait, Ph.D., CEO of Cleveland Diagnostics. “Given this new information, we believe that IsoPSA holds considerable potential to shift the paradigm for prostate cancer detection and management.”

“Our study demonstrates considerable cost savings associated with the reduction in the volume of biopsies among this cohort of patients,” said Yair Lotan, MD, lead author of the study and Professor of Urology, Chief of Urologic Oncology, and Jane and John Justin Distinguished Chair in Urology, In Honor of Claus G. Roehrborn, M.D. at UT Southwestern Medical Center. “We have been studying IsoPSA alongside of Cleveland Diagnostics for many years, and are hopeful that IsoPSA will now reduce the number of biopsies required in actual clinical practice among men with prior negative biopsy with continued suspicion for cancer.”

“We are pleased to see that the overall diagnostic accuracy of IsoPSA should translate into significant savings to health plans,” added Bob Rochelle, Chief Commercial Officer of Cleveland Diagnostics, and co-author of the study. “Reducing the number of unneeded biopsies will not only help lower 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 those patients that need them most, thereby improving the safety and efficacy of prostate cancer early detection while simultaneously realizing substantial savings to patients and payers.”

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

About Cleveland Diagnostics, Inc.

Cleveland Diagnostics, Inc., is a commercial-stage diagnostics company developing highly efficacious, lab-friendly, affordable diagnostics tests using proprietary technology to improve cancer diagnostics. Its Solvent Interaction Analysis™ (SIA) technology investigates protein biomarkers at the structural level (as opposed to overall biomarker concentration in blood), providing better and more direct insights regarding the protein biomarker origin on the cellular level, thus improving test specificity to the underlying disease process. Its portfolio of non-invasive cancer diagnostics will be expanding from prostate cancer to breast cancer and lung cancer, infectious diseases, and certain neurological diseases, such as Alzheimer’s disease. Visit us at and

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


Cleveland Diagnostics, Inc.
Bob Rochelle
Phone: 216 432-2700, Ext. 2119

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Last Updated: 13-Jan-2021