FDA approves Cleveland Diagnostics’ novel blood-based prostate cancer test
Test helps to identify patients at high risk who need intervention or closer monitoring
5 Dec 2025
Cleveland Diagnostics has announced that the U.S. Food and Drug Administration (FDA) has approved the company’s IsoPSA® in vitro diagnostic (IVD) kit through the Premarket Approval (PMA) process.
IsoPSA is a blood-based test indicated as an aid in the decision for prostate biopsy for men ≥50 years of age with elevated prostate-specific antigen (PSA) levels.
The IsoPSA IVD kit leverages Cleveland Diagnostics’ IsoClear™ platform. This proprietary technology investigates protein biomarkers at a structural level in the blood to provide clinically relevant insights into disease state.
FDA approval of the IsoPSA test was based on clinical evidence from a large-scale prospective study conducted at 14 sites across the U.S. and data from supporting analytical validation studies.
Prostate cancer is the second most common cancer in American men, with 1 in 8 diagnosed during their lifetime. In the U.S., greater than1 million men undergo prostate biopsies each year, yet up to 75% of those follow-up tests are negative for high-grade disease.
This diagnostic gap subjects millions to invasive, costly procedures that can produce physical risks, emotional stress, and significant healthcare costs. IsoPSA helps close this gap, giving clinicians and patients a more accurate risk assessment and greater confidence in biopsy decision-making.
"As a practicing urologist, I see first hand how the limitations of current PSA testing can lead to unnecessary procedures and anxiety for patients and appreciate the critical need for early and accurate risk assessment and testing," added Dr. Aaron Berger, Chief Medical Officer and Director of Clinical Research at Associated Urological Specialists in Chicago.“IsoPSA represents a meaningful advancement, giving physicians a tool that improves risk assessment and helps us make more informed biopsy decisions with greater confidence.”