This material concerns IsoPSA, a laboratory developed test from Cleveland Diagnostics, Inc., which is regulated under CLIA and qualified to perform high‑complexity clinical testing. As an …

Dec 1, 2025 · IsoPSA, a blood-based test, aids in diagnosing high-grade prostate cancer by analyzing PSA protein structural variants. FDA approval was based on a large-scale, …

IsoPSA® - IsoPSA is a structure-based (rather than concentration- based) assay that interrogates the entire spectrum of structural changes to PSA (or isoforms), and can effectively differentiate …

Dec 2, 2025 · IsoPSA is FDA-approved for evaluating prostate cancer-specific structural variants of PSA in men over 50, aiding biopsy decisions. The test addresses the diagnostic gap, …

What Is IsoPSA? IsoPSA is a novel assay for prostate cancer that measures structural changes in PSA by calculating

Jan 21, 2021 · The IsoPSA test is a novel prostate-specific antigen assay for patients with a PSA > 4ng/ml who are facing a decision on prostate biopsy. Listen as Dr. Klein discusses how the …

Jul 3, 2025 · Compared with traditional prostate-specific antigen (PSA) testing, IsoPSA offers significantly improved specificity, helping clinicians reduce unnecessary prostate biopsies by …

Dec 1, 2025 · IsoPSA is a novel blood-based test approved for diagnosing high-grade prostate cancer in men over 50 with elevated PSA levels. The test evaluates structural variants of the …

Dec 1, 2025 · IsoPSA, approved by the FDA, offers a blood-based tool for better prostate cancer risk assessment, reducing unnecessary biopsies in men over 50 with elevated PSA levels.

Dec 4, 2025 · The FDA has approved Cleveland Diagnostics’ IsoPSA blood test. This novel diagnostic tool helps physicians decide on the necessity of a prostate biopsy for men with …