FDA Approves New IsoPSA Blood Test to Pinpoint Aggressive Prostate Cancer

The FDA has approved a novel blood test called IsoPSA that helps pinpoint aggressive prostate cancer in men over 50 with elevated PSA levels, potentially sparing many from unnecessary biopsies.

Unlike the standard PSA screening, which often flags noncancerous issues and can send men for unwarranted biopsies, IsoPSA examines structural changes in the PSA protein that are specifically linked to prostate tumours.

In a large study across multiple medical centers in the United States, this approach caught about 90% of high-grade prostate cancers while filtering out enough low-risk cases to cut biopsy recommendations by more than half. By focusing on the protein’s shape rather than just its quantity, IsoPSA gives doctors a clearer risk profile to guide decisions.

Urologists are calling the test a major advance, noting that it could reduce patient anxiety and the complications of unneeded procedures. It has already been added to key clinical guidelines (like those from NCCN) to help determine when a biopsy is truly necessary.

This news sits firmly within Hall 1: Precision & Molecular Diagnostics, highlighting next-generation assays that refine detection and clinical decision-making for high-impact diseases.