Cleveland Diagnostics Announces FDA Breakthrough Device Designation for Novel Prostate Cancer Diagnostic Test


Cleveland Diagnostics, Inc., a clinical-stage company focused on developing next-generation diagnostic tests for the early detection of cancers, announced that it has received FDA Breakthrough Device Designation for the IsoPSA® Assay, a novel prostate cancer diagnostic test. Published studies from multicenter prospective clinical trials suggest that the non-invasive, blood-based IsoPSA assay has significant superior diagnostic accuracy when compared to traditional prostate-specific antigen (PSA) tests in detecting high-grade prostate cancer.

FDA Breakthrough Device designation is granted to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Through the Breakthrough Device Program, Cleveland Diagnostics will work more closely and frequently with the FDA to expedite its review of IsoPSA.

“We are very grateful that FDA recognizes the potential of IsoPSA, the first test in our pipeline of simple, affordable, and highly accurate cancer tests that focus on cancer-relevant changes to protein biomarkers in blood,” said Arnon Chait, Ph.D., CEO of Cleveland Diagnostics. “We look forward to working closely with the FDA to expedite the appropriate approvals and get this important new test into the hands of physicians.”

Cleveland Diagnostics has concluded two multicenter clinical trials in top U.S. and international hospitals and clinics, led by Cleveland Clinic, in which the diagnostic accuracy of IsoPSA was compared to that of PSA, the current standard of care in prostate cancer, in men scheduled for prostate biopsy. The results from those studies demonstrated that IsoPSA has superior diagnostic performance to traditional PSA in identifying which patients have high-grade disease.

“The clinical utility of PSA is limited by the relatively poor diagnostic accuracy and predictive value of the test,” said Mark Stovsky, M.D., CMO at Cleveland Diagnostics 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.”

It is estimated that 1 in 9 men will develop prostate cancer in their lifetime. The results of previous studies have shown that IsoPSA could reduce unnecessary biopsies by at least 45 percent, saving men from unneeded invasive, potentially risky and expensive procedures that can sometimes lead to serious and lasting side effects.

About Cleveland Diagnostics, Inc.

Cleveland Diagnostics, Inc., is a clinical-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 biomarkers at the structural level as opposed to overall concentration, providing better insights as to the protein origin, improving their specificity to the underlying disease process. Its portfolio of non-invasive cancer diagnostics include prostate and breast cancer, and Alzheimer’s disease. Visit us at