Cleveland Diagnostics, a commercial-stage precision oncology company, has announced that the US FDA has granted approval for its IsoPSA in vitro diagnostic (IVD) kit through the Premarket Approval (PMA) process. The blood-based test is designed to aid in the decision for prostate biopsy in men aged 50 and older 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,” said Arnon Chait, company president and CEO. “We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide.”

 

The FDA’s decision was supported by clinical evidence from a large-scale, prospective study conducted at 14 sites across the US, alongside supporting analytical validation data.

 

Prostate cancer is the second most common cancer in American men, with 1 in 8 diagnosed during their lifetime. Each year, over 1 million men in the U.S. undergo prostate biopsies, yet up to 75% of follow-up tests return negative for high-grade disease. IsoPSA aims to close this diagnostic gap, providing clinicians and patients with more accurate risk assessment and greater confidence in biopsy decisions.

 

“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,” said 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,” added Dr Eric Klein, Emeritus Chair of the Glickman Urological & Kidney Institute at Cleveland Clinic and Distinguished Scientist at GRAIL. “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 uses Cleveland Diagnostics’ proprietary IsoClear platform, which examines protein biomarkers at a structural level in the blood to deliver clinically relevant insights into disease state.

 

IsoPSA has been offered as a Laboratory-Developed Test (LDT) since 2020, with coverage now provided by Medicare and an increasing number of commercial payors.