Cleveland Diagnostics Announces Preliminary Results From Multicenter IsoPSA Study Demonstrating Significantly Improved Accuracy Over Standard Prostate-Specific Antigen (PSA) Test

CLEVELAND--(BUSINESS WIRE)--Cleveland Diagnostics, Inc., a biotechnology company focused on developing next-generation diagnostics for the detection of cancers, today announced the online publication of interim results for an ongoing multi-center trial of the IsoPSA™ prostate cancer test in European Urology. The findings illustrate a significantly improved diagnostic accuracy over the current gold standard, prostate-specific antigen (PSA), for both detection of any prostate cancer as well as high-grade prostate cancer.

The study, led by Eric Klein, M.D., Chairman of Cleveland Clinic’s Glickman Urological & Kidney Institute, involved researchers from Cleveland Clinic, Kaiser Permanente Northwest, Michigan Institute of Urology, and other clinical sites.

PSA has been the mainstay test in screening and diagnosing of prostate cancer for over two decades, but its sensitivity to cancer is negated by its lack of specificity for the same, resulting in millions of unnecessary biopsies and billions of precious healthcare dollars wasted annually,” said Arnon Chait, Ph.D., CEO of Cleveland Diagnostics. “We are very pleased with the results obtained by some of the key opinion leaders in the field, and we hope to use data from this and follow-on studies to complete the validation for clinical use.”

The multicenter study compared the diagnostic accuracy of Cleveland Diagnostics’ IsoPSA™ technology to PSA, the current standard in prostate cancer, in men scheduled for prostate biopsy. The results demonstrated that IsoPSA™ is significantly better than PSA in both determining whether a patient has prostate cancer and identifying patients at risk for high-grade disease, a critical distinction given the slow progression of many prostate cancers and the shift to active surveillance in properly selected patients.

The technology underlying IsoPSA™ represents a transformational departure in how cancer biomarkers are defined. Instead of asking the non-specific question of how much of a biomarker, such as PSA, is circulating in blood, our test essentially identifies the type of PSA that originates only from cancer cells,” said Chait. The results of the study show that the non-invasive, blood-based IsoPSA™ could, if adopted clinically, reduce unnecessary biopsies by as much as 50 percent.

While the United States Preventative Services Task Force (USPSTF) recently updated its assessment of PSA as a screening tool for prostate cancer from a “D” to a “C” grade, questions regarding the diagnostic accuracy of PSA in prostate cancer screening and early detection paradigms remain.

The clinical utility of PSA to primary care providers and urologists is limited by the relatively poor diagnostic accuracy and predictive value of the test,” said Mark Stovsky, M.D., co-author and urologist at Cleveland Clinic. “Clinicians today are using an array of diagnostic tests and procedures to inform decisions about a patient’s prostate health and the risk of prostate cancer. We believe that IsoPSA™ has the potential to fill a major void in this space.”

Dr. Klein has no personal financial interest in the company. Dr. Stovsky has a leadership position (Chief Medical Officer) and investment interest in Cleveland Diagnostics, Inc.

About Cleveland Diagnostics, Inc.

Cleveland Diagnostics, Inc., is a clinical-stage biotechnology company developing technology to improve cancer diagnostics. Its Solvent Interaction Analysis (SIA) technology investigates biomarkers at the structural level as opposed to overall concentration, giving better insights as to its cellular origin. Its pipeline of high performance, non-invasive cancer diagnostics include tests for prostate cancer, breast cancer, and Alzheimer’s disease. Visit us at

For more information, please email

Cleveland Diagnostics, Inc.
Erich Heise, 216-432-2700

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