FDA Approves IsoPSA Blood Test to Reduce Unnecessary Prostate Biopsies
核心洞察
The FDA approved Cleveland Diagnostics (搜索)' IsoPSA (搜索) blood test on December 1, 2025, as an aid in prostate biopsy decision-making for men 50 years and older with elevated PSA (搜索) levels.
The test analyzes prostate cancer-specific structural variants of the PSA (搜索) protein to distinguish benign PSA elevations from those caused by high-grade cancer.
FDA approval was based on a large-scale prospective study conducted at 14 U.S. sites, addressing the critical need to reduce unnecessary biopsies in the over 1 million men who undergo the procedure annually.
Cleveland Diagnostics (搜索) announced that the U.S. Food and Drug Administration has approved its IsoPSA (搜索) in vitro diagnostic kit through the Premarket Approval process on December 1, 2025. The blood-based test is indicated as an aid in the decision for prostate biopsy for men 50 years of age and older with elevated PSA (搜索) levels.
Addressing a Critical Diagnostic Gap
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.
"As a practicing urologist, I see firsthand how the limitations of current PSA (搜索) testing can lead to unnecessary procedures and anxiety for patients and appreciate the critical need for early and accurate risk assessment and testing," said Dr. Aaron Berger, Chief Medical Officer and Director of Clinical Research at Associated Urological Specialists (搜索) in Chicago. "IsoPSA (搜索) represents a meaningful advancement, giving physicians a tool that improves risk assessment and helps us make more informed biopsy decisions with greater confidence."
Novel Protein Structure Analysis
The IsoPSA (搜索) test evaluates prostate cancer-specific structural variants of the PSA (搜索) protein to aid in the diagnosis of high-grade prostate cancer. The test leverages Cleveland Diagnostics (搜索)' proprietary IsoClear platform, which investigates protein biomarkers at a structural level in the blood to provide clinically relevant insights into disease state.
"FDA approval underscores the value and clinical utility of IsoPSA (搜索) in distinguishing benign elevations of PSA (搜索) from those due to high grade cancer," said Dr. Eric Klein, Emeritus Chair of the Glickman Urological & Kidney Institute at Cleveland Clinic and Distinguished Scientist at GRAIL, Inc. "I'm very pleased to see this milestone achieved; it represents the culmination of extensive study and test development over the past decade."
Clinical Evidence and Validation
FDA approval of the IsoPSA (搜索) 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. The test is currently 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).
Commercial Strategy and Access
Cleveland Diagnostics (搜索) has offered IsoPSA (搜索) as a Laboratory-Developed Test since 2020, and Medicare and a growing number of commercial payors now cover the test. "FDA approval of our IsoPSA kit marks a significant milestone in Cleveland Diagnostics' mission to help physicians and patients detect cancer early when it is most treatable and survivable," said Arnon Chait, PhD, company president and CEO. "We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide."