Posted by Michael Wonder on 04 Dec 2025
FDA approves IsoPSA - Cleveland Diagnostics’ novel blood based prostate cancer test
1 December 2025 - Cleveland Diagnostics announced today that the US FDA has approved the company’s IsoPSA in vitro diagnostic kit through the premarket approval 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.
