Health Economic Analysis Publication Shows IsoPSA® Dramatically Reduces Biopsies and Unnecessary Prostate Cancer Costs



Cleveland Diagnostics, Inc., a clinical-stage biotechnology company focused on developing next-generation diagnostic tests for the early detection of cancers, today announced the publication of a health economics 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 for the IsoPSA test based on previous clinical evidence of its effectiveness over a standard care workup to guide the need for a new prostate biopsy. The present study evaluated the cost-effectiveness of IsoPSA for the detection of a high-grade disease, potentially leading to clinical action, which may lead to downstream treatment of primary cancer. Inputs to the model included established determinants of IsoPSA diagnostic accuracy (i.e., among patients requiring repeat biopsies, the econometric model indicated that use of IsoPSA overall reduced the number of biopsies required by 34%, resulting in 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 urological institutions across the country, have demonstrated that IsoPSA has improved diagnostic accuracy and has the potential to reduce significantly unnecessary biopsies compared to clinical decision-making using current standard PSA testing. This rigorous analysis of health outcomes now confirms that IsoPSA has the potential to generate substantial savings for payers, including plans. private and public health, “said Arnon Chait, Ph.D., CEO of Cleveland Diagnostics.” Given this new information, we believe that IsoPSA holds considerable 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, chief of urologic oncology, and Jane and John Justin Distinguished 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 we hope that IsoPSA will now reduce the number of biopsies required in actual clinical practice in previously negative biopsy men with a continuing suspicion of cancer.”

“We are delighted 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 simultaneously achieving substantial savings for patients and payers. “

It is estimated that 1 in 9 men will develop prostate cancer in 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 diagnostic company developing highly efficient, user-friendly and affordable diagnostic tests using proprietary technology to improve cancer diagnosis. Its Solvent Interaction Analysis â„¢ (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 test for the underlying disease process. Its portfolio of non-invasive cancer diagnostics 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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Cleveland Diagnostics, Inc.
Bob Rochelle
Telephone: 216 432-2700, ext. 2119
[email protected].com



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