> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Firm Gets Breakthrough Status for Prostate Cancer Test
- URL: https://www.fdaweb.com/firm-gets-breakthrough-status-for-prostate-cancer-test/
- Published: 2019-10-16T12:00:00.000Z
- Updated: 2026-09-15T01:57:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145271

FDA has granted Cleveland Diagnostics a breakthrough device designation for the IsoPSA Assay, a prostate cancer diagnostic test. The designation was based on data from multicenter prospective clinical trials that suggest that the non-invasive, blood-based IsoPSA assay has superior diagnostic accuracy when compared to traditional prostate-specific antigen (PSA) tests in detecting high-grade prostate cancer, according to the company. “The results of previous studies have shown that IsoPSA could reduce unnecessary biopsies by at least 45%, saving men from unneeded invasive, potentially risky and expensive procedures that can sometimes lead to serious and lasting side effects,” it says.