The test is intended to help determine the need for a prostate biopsy in patients with higher PSA levels. Credit: R Photography Background / Shutterstock.com.

The US Food and Drug Administration (FDA) has granted approval for Cleveland Diagnostics’ IsoPSA in vitro diagnostic (IVD) kit, designed as an aid for physicians in deciding on prostate biopsy for men aged 50 years and older who present with elevated prostate-specific antigen (PSA) levels.

The blood-based test was approved via the premarket approval (PMA) process.

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The FDA’s decision is supported by clinical evidence from a prospective trial carried out at 14 US sites, as well as data from supporting analytical validation trials.

IsoPSA utilises the company’s IsoClear platform, which analyses protein biomarkers at a structural level in blood samples to generate information related to the status of the disease.

IsoClear analyses the structure of proteins to identify their origin, helping to assess whether a patient may have cancer.

Cleveland Diagnostics CEO and president Arnon Chait said: “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.

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“We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide.”

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

The company claims to have provided IsoPSA as a laboratory-developed test since 2020.

Cleveland Clinic Glickman Urological & Kidney Institute Emeritus chair Dr Eric Klein said: “FDA approval underscores the value and clinical utility of IsoPSA in distinguishing benign elevations of PSA from those due to high grade cancer.”

Dr Klein is also a shareholder of Cleveland Diagnostics.

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