The test receives premarket approval as an aid in biopsy decision-making for men 50 and older with elevated PSA levels.
The US Food and Drug Administration (FDA) has approved Cleveland Diagnostics’ IsoPSA in vitro diagnostic kit through the premarket approval process. The blood-based test is indicated as an aid in prostate biopsy decision-making for men 50 years and older with elevated PSA levels.
The approval was based on clinical evidence from a large-scale, prospective study conducted at 14 sites across the US and data from supporting analytical validation studies.
“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,” says Arnon Chait, PhD, company president and CEO, in a release. “We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide.”
Addressing Diagnostic Gap in Prostate Cancer
The approval addresses a diagnostic challenge in prostate cancer screening. More than 1 million men undergo prostate biopsies annually in the US, yet up to 75% of those follow-up tests are negative for high-grade disease, subjecting patients to invasive procedures that carry physical risks, emotional stress, and healthcare costs, according to a release from Cleveland Diagnostics.
“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,” says Aaron Berger, MD, chief medical officer and director of clinical research at Associated Urological Specialists in Chicago, in a release. “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 IVD kit leverages Cleveland Diagnostics’ IsoClear platform, a proprietary technology that investigates protein biomarkers at a structural level in blood to provide clinical insights into disease state.
Clinical Validation and Market Access
Cleveland Diagnostics has offered IsoPSA as a laboratory-developed test since 2020, with Medicare and a growing number of commercial payers now covering the test. The test is included in clinical practice guidelines, including the National Cancer Network Prostate Cancer Early Detection Guideline (2025) and the Early Detection of Prostate Cancer: American Urology Association/Society of Urologic Oncology Guideline (2023).
“FDA approval underscores the value and clinical utility of IsoPSA in distinguishing benign elevations of PSA from those due to high-grade cancer,” says Eric Klein, MD, emeritus chair of the Glickman Urological & Kidney Institute at Cleveland Clinic and distinguished scientist at GRAIL Inc, in a release. “I’m very pleased to see this milestone achieved; it represents the culmination of extensive study and test development over the past decade.”
Prostate cancer is the second most common cancer in American men, with 1 in 8 diagnosed during their lifetime, according to the company.
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