New Blood Test IsoPSA Avoids Unnecessary Prostate Biopsies
- 2 days ago
- 2 min read
The U.S. Food and Drug Administration (FDA) has granted approval for Cleveland Diagnostics' IsoPSA in vitro diagnostic (IVD) kit. This decision marks a significant advancement in prostate cancer risk assessment, providing physicians with an important new tool. Approved via the premarket approval (PMA) process, the blood-based test is intended to assist physicians in deciding on the necessity of a prostate biopsy for men aged 50 years and older who have elevated prostate-specific antigen (PSA) levels.
Prostate cancer is the second most common cancer in American men. While over one million men undergo prostate biopsies each year in the U.S., studies show that as many as 75% of those follow-up tests are negative for high-grade disease. This diagnostic gap exposes millions to invasive, costly procedures that carry physical risks and emotional stress.
IsoPSA aims to close this gap by providing a more accurate risk assessment. The test leverages Cleveland Diagnostics’ IsoClear platform to analyze protein biomarkers at a structural level in blood samples. Unlike traditional PSA screening, IsoPSA evaluates cancer-specific structural variants of the PSA protein to identify the origin of the proteins, helping to assess whether a patient may have high-grade cancer.
Dr. Eric Klein, Emeritus chair of the Cleveland Clinic Glickman Urological & Kidney Institute, stated that the FDA approval underscores the clinical utility of IsoPSA in distinguishing benign elevations of PSA from those due to high grade cancer. Urologists recognize the critical need for early and accurate risk assessment, noting that current PSA testing limitations often lead to unnecessary procedures and anxiety.
The FDA's decision was based on clinical evidence from a large-scale, prospective study conducted at 14 sites across the U.S., supported by analytical validation trials. The company has been offering IsoPSA as a laboratory-developed test (LDT) since 2020. Furthermore, IsoPSA is already included in leading clinical practice guidelines, such as 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).
Arnon Chait, CEO and president of Cleveland Diagnostics, emphasized that the approval marks a "significant milestone" in the company's mission to help physicians and patients detect cancer early when it is most treatable and survivable. The company remains focused on expanding access to the test nationwide.
🔖 Sources
Keywords: IsoPSA Avoids Unnecessary Prostate Biopsies
IsoPSA Avoids Unnecessary Prostate Biopsies
