CLEVELAND, Ohio — The U.S. Food and Drug Administration has approved IsoPSA, a novel blood-based diagnostic test developed by Cleveland Diagnostics, Inc., for use in assessing the risk of high-grade prostate cancer in men age 50 and older with elevated PSA levels. The approval, granted through the Premarket Approval pathway, marks a major milestone for the precision oncology company as it expands national access to the test.
IsoPSA evaluates structural variants of the PSA protein associated specifically with prostate cancer, offering a more accurate risk assessment compared with traditional PSA testing. The FDA’s decision was supported by results from a large prospective clinical study conducted at 14 sites across the United States, along with comprehensive analytical validation data.
Arnon Chait, Ph.D., president and CEO of Cleveland Diagnostics, said the approval advances the company’s mission of improving early cancer detection. “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,” he said. “We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide.”
Prostate cancer is the second most common cancer among American men, with 1 in 8 diagnosed during their lifetime. More than one million U.S. men undergo prostate biopsies each year, yet an estimated 75 percent of those procedures are negative for high-grade disease. Current testing limitations often lead to unnecessary, invasive procedures that carry physical, emotional and financial burdens. IsoPSA aims to close this diagnostic gap by providing clinicians with clearer insight into whether elevated PSA levels are likely due to aggressive cancer.
“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.”
Dr. Eric Klein, emeritus chair of the Glickman Urological & Kidney Institute at Cleveland Clinic and distinguished scientist at GRAIL, Inc., said the approval reflects a decade of research and development. “FDA approval underscores the value and clinical utility of IsoPSA in distinguishing benign elevations of PSA from those due to high grade cancer,” he said. “I’m very pleased to see this milestone achieved; it represents the culmination of extensive study and test development over the past decade.”
IsoPSA is built on the company’s IsoClear platform, which analyzes protein biomarkers based on structural characteristics to provide clinically relevant insights into disease. The test has been available as a laboratory-developed test since 2020 and is covered by Medicare and an increasing number of commercial insurers. It is also included in key clinical guidelines, including the National Comprehensive Cancer Network’s 2025 prostate cancer early detection recommendations and the 2023 American Urological Association/Society of Urologic Oncology prostate cancer screening guideline.
