Shots:
- The US FDA has granted a PMA to the IsoPSA in vitro diagnostic (IVD) kit for the diagnosis of high-grade prostate cancer
- Approval was based on the clinical evidence from a prospective study of the IsoPSA test conducted at 14 sites across the US, as well as data from supporting analytical validation studies
- IsoPSA, a blood-based test for men (≥50yrs.) with elevated PSA that aids prostate biopsy decisions via the IsoClear platform’s structural protein analysis, is included in major clinical guidelines, incl. NCCN (2025) & AUA/SUO Early Detection (2023)
Ref: Businesswire | Image: Cleveland Diagnostics| Press Release
Related News: GE HealthCare Seeks the US FDA 510(k) Clearance for SIGNA MRI technology to Advance Precision Diagnostics
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information connect with us at connect@pharmashots.com
