FDA approves IsoPSA test as aid in the diagnosis of high-grade prostate cancer

On December 1, 2025, the FDA approved IsoPSA, a blood-based test to aid in the diagnosis of high-grade prostate cancer, Cleveland Diagnostics announced in a news release.¹

The in vitro diagnostic kit was approved through the premarket approval process. The test works by analyzing “prostate cancer-specific structural variants of the prostate-specific antigen (PSA) protein” to aid in the decision for prostate biopsy in men who are 50 years of age or older with elevated PSA levels.

“FDA approval underscores the value and clinical utility of IsoPSA in distinguishing benign elevations of PSA from those due to high grade cancer,” said Eric A. Klein, MD, Emeritus Chair of the Glickman Urological & Kidney Institute at Cleveland Clinic, in the news release.¹ “I’m very pleased to see this milestone achieved; it represents the culmination of extensive study and test development over the past decade.”

The approval is supported by results from a large-scale, prospective study conducted across 14 clinical trial sites in the US, as well as from other supporting validation studies.

“As a practicing urologist, I see firsthand how the limitations of current PSA testing can lead to unnecessary procedures and anxiety for patients and appreciate the critical need for early and accurate risk assessment and testing,” added Aaron Berger, MD, chief medical officer and director of clinical research at Associated Urological Specialists in Chicago, Illinois, in the news release.¹ “IsoPSA represents a meaningful advancement, giving physicians a tool that improves risk assessment and helps us make more informed biopsy decisions with greater confidence.”

The IsoPSA test is currently included in the National Comprehensive Cancer Network (NCCN) Prostate Cancer Early Detection Guideline (2025) and the Early Detection of Prostate Cancer: American Urology Association/Society of Urologic Oncology Guideline (2023).

According to Cleveland Diagnostics, the company “has offered IsoPSA as a Laboratory-Developed Test (LDT) since 2020, and Medicare and a growing number of commercial payors now cover the test.”

“FDA approval of our IsoPSA kit marks a significant milestone in Cleveland Diagnostics’ mission to help physicians and patients detect cancer early when it is most treatable and survivable,” concluded Arnon Chait, PhD, MBA, president and CEO of Cleveland Diagnostics, in the news release.¹ “We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide.”

REFERENCE

1. FDA Approves IsoPSA® -- Cleveland Diagnostics’ Novel Blood-Based Prostate Cancer Test. News release. Cleveland Diagnostics, Inc. December 1, 2025. Accessed December 1, 2025. https://www.businesswire.com/news/home/20251201324198/en/FDA-Approves-IsoPSA----Cleveland-Diagnostics-Novel-Blood-Based-Prostate-Cancer-Test