Cleveland Diagnostics Presents New Data Supporting the Clinical Validation and Clinical Utility of IsoPSA at the 2021 Annual Meeting of American Urological Association

IsoPSA clinically validated in a study of over 1000 patients and demonstrates significant clinical utility in a study of 900 patients in a real-world setting

CLEVELAND–(BUSINESS WIRE)–Cleveland Diagnostics, Inc., a commercial stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, announced today that Eric Klein, MD, Chairman of the Glickman Urological & Kidney Institute at Cleveland Clinic, delivered two presentations at the annual meeting of the American Urological Association regarding the company’s prostate cancer test, IsoPSA.

In the first presentation, entitled “IsoPSA: Clinical Performance of a Single Parameter, Structure Based Test for High Grade Prostate Cancer in a Large, Multicenter, Prospective Validation Trial”, Dr. Klein provided data used to validate the diagnostic accuracy of the novel, structure-based IsoPSA assay to improve early detection strategies for prostate cancer vs. standard of care PSA and % free PSA tests. In the prospective, multicenter study of 1,093 men IsoPSA showed an AUC of 0.790 for the detection of high grade cancer (Gleason grade group 2 or higher) (vs. 0.674 for PSA and 0.727 for % free PSA). IsoPSA had a sensitivity of 90% for high-grade prostate cancer, and specificity of 47% (compared to 21% for PSA and 14% for % free PSA). Data were consistent and reliable across patients who were biopsy naïve and who had a prior negative biopsy, and IsoPSA maintained its statistical accuracy across a wide range of elevated PSA values (from 4ng/mL to 100ng/mL).

In the second presentation, entitled “IsoPSA Reduces Provider Recommendations for Biopsy and MRI in Men with Total PSA ≥ 4ng/mL: A Real-World Observational Clinical Utility Study”, Dr. Klein reported that 38 providers practicing in a variety of clinical settings evaluating 900 patients for prostate cancer substantially altered their behavior and patient management decisions following IsoPSA testing. Provider recommendations for biopsy and MRI were modified post-IsoPSA in 66% of cases in this prospective study, and concordance between IsoPSA results and biopsy recommendations was very high. Overall, IsoPSA test results reduced provider biopsy recommendations by 55% and MRI recommendations by 9%. In twenty cases, biopsies that were recommended after, but not before, IsoPSA testing, led to the detection of additional prostate cancers that would have been missed had it not been for IsoPSA testing.

“The data from these two studies demonstrate that IsoPSA is not only effective at detecting high-grade prostate cancer, but also holds promise to change the diagnostic paradigm, which could result in both improved patient outcomes and reduced costs to the healthcare system,” said Eric Klein, MD.

“The real world implications of these findings are important and considerable,” added Arnon Chait, PhD, CEO of Cleveland Diagnostics, Inc. “Using IsoPSA, we believe that providers save lives, and save the healthcare system considerable money while doing so. Reducing the number of unnecessary biopsies, increasing biopsy yield, and distinguishing high grade disease risk from low grade or benign disease with an effective blood test will be critical to savings lives, costs, and significantly improve overall patient care.”

The 2021 American Urological Association annual meeting was held virtually this year from September 10-13, 2021. More information can be found at www.aua2021.org.

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 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, and certain neurological diseases. Visit us at ClevelandDx.com and IsoPSA.com.

Contacts

Cleveland Diagnostics, Inc.

Bob Rochelle

Phone: (216) 432-2700, Ext. 2119

[email protected]