FDA approves next-gen PSA test from Cleveland Diagnostics
Dec 3, 2025 · The FDA has approved a novel diagnostic for prostate cancer that looks to improve upon the common screener for prostate-specific antigen, known as a PSA test. The IsoPSA blood test, …
FDA Approves Novel Blood-Based Prostate Cancer Test for Elevated …
Dec 2, 2025 · The FDA has approved IsoPSA® in vitro diagnostic kit as an aid in the decision for prostate biopsy for male patients 50 years or older who have elevated prostate-specific antigen …
FDA approves IsoPSA test as aid in the diagnosis of high-grade prostate ...
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, prospective study and …
FDA Approves IsoPSA® — Cleveland Diagnostics’ Novel Blood-Based ...
Dec 1, 2025 · IsoPSA Test Evaluates Prostate Cancer-Specific Structural Variants of the PSA Protein to Aid in the Diagnosis of High-Grade Prostate Cancer Cleveland Diagnostics, Inc., a pioneering, …
FDA Approves IsoPSA Blood Test to Detect Prostate Cancer
Dec 2, 2025 · The FDA approved a blood-based test, IsoPSA (Cleveland Diagnostics, Inc.), to evaluate prostate cancer-specific structural variants of the PSA protein in men 50 years of age and older.
Cleveland Diagnostics’ IsoPSA secures FDA approval for prostate cancer
Dec 2, 2025 · The US Food and Drug Administration (FDA) has granted approval for Cleveland Diagnostics’ IsoPSA in vitro diagnostic (IVD) kit, designed as an aid for physicians in deciding on …
FDA Approves IsoPSA Blood-Based Prostate Cancer Test as …
Dec 1, 2025 · The FDA has approved the IsoPSA in vitro diagnostic kit—a novel blood-based prostate cancer test—for use as an aid in the diagnosis of high-grade prostate cancer in men at least 50 …
FDA approves Cleveland Diagnostics’ novel blood-based prostate …
Dec 5, 2025 · Cleveland Diagnostics has announced that the FDA has approved the company’s IsoPSA® in vitro diagnostic (IVD) kit through the Premarket Approval (PMA) process. IsoPSA is a …
FDA approves IsoPSA diagnostic test to improve prostate biopsy …
Dec 1, 2025 · Key Takeaways 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 …
FDA Approves Novel Blood-Based Assay to Stratify Prostate Cancer …
Dec 1, 2025 · The FDA has granted premarket approval (PMA) to the IsoPSA test, a novel, blood-based in vitro diagnostic kit designed to assist clinicians in deciding whether to proceed with prostate biopsy …