FDA approves Cleveland Diagnostics' IsoPSA Test for prostate cancer detection
Cleveland Diagnostics, Inc. 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 PSA levels.
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 than 1 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.
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.
Cleveland Diagnostics has offered IsoPSA as a Laboratory-Developed Test (LDT) since 2020, and Medicare and a growing number of commercial payors now cover the test. IsoPSA is included in leading clinical practice guidelines, including the National Comprehensive Cancer Network (NCCN) Prostate Cancer Early Detection Guideline (2025) and the Early Detection of Prostate Cancer: American Urology Association/Society of Urologic Oncology Guideline (2023).
