FDA Approves IsoPSA® -- Cleveland Diagnostics’ Novel Blood-Based Prostate Cancer Test

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5:00 AM on Monday, December 1

The Associated Press

CLEVELAND--(BUSINESS WIRE)--Dec 1, 2025--

Cleveland Diagnostics, Inc., a pioneering, commercial-stage precision oncology company, announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s IsoPSA® in vitro diagnostic (IVD) kit through the Premarket Approval (PMA) 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.

“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,” shared Arnon Chait, PhD, company president and CEO. “We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide.”

FDA approval of the IsoPSA test was based on clinical evidence from a large-scale, prospective study conducted at 14 sites across the U.S. and data from supporting analytical validation studies.

Prostate cancer is the second most common cancer in American men, with 1 in 8 diagnosed during their lifetime. In the U.S., greater than 1 million men undergo prostate biopsies each year, yet up to 75% of those follow-up tests are negative for high-grade disease. This diagnostic gap subjects millions to invasive, costly procedures that can produce physical risks, emotional stress, and significant healthcare costs. IsoPSA helps close this gap, giving clinicians and patients a more accurate risk assessment and greater confidence in biopsy decision-making.

“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 Dr. Aaron Berger, Chief Medical Officer and Director of Clinical Research at Associated Urological Specialists in Chicago. “IsoPSA represents a meaningful advancement, giving physicians a tool that improves risk assessment and helps us make more informed biopsy decisions with greater confidence.”

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

The IsoPSA IVD kit leverages Cleveland Diagnostics’ IsoClear™ platform. This proprietary technology investigates protein biomarkers at a structural level in the blood to provide clinically relevant insights into disease state.

Cleveland Diagnostics has offered IsoPSA as a Laboratory-Developed Test (LDT) since 2020, and Medicare and a growing number of commercial payors now cover the test. IsoPSA is included in leading clinical practice guidelines, including 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).

For more information and company news, visit ClevelandDx.com

About Cleveland Diagnostics, Inc.

Cleveland Diagnostics is a precision oncology company focused on changing the shape of cancer detection. The company has unlocked the diagnostic power of protein structure with its revolutionary IsoClear™ platform that enables novel diagnostics based on a cancer-specific, protein structure-based assessment using easy to execute tests within the clinical lab setting.

Learn more at ClevelandDx.com and IsoPSA.com.

*Dr. Eric Klein who is quoted in this release, is a shareholder of Cleveland Diagnostics, Inc.

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