IsoPSA has been FDA approved for use as an aid in the diagnosis of high-grade prostate cancer in men at least 50 years of age with elevated PSA levels.
The FDA has approved the IsoPSA in vitro diagnostic kit—a novel blood-based prostate cancer test—through the premarket approval process for use as an aid in the diagnosis of high-grade prostate cancer in men at least 50 years of age with elevated prostate-specific antigen (PSA) levels.1
This approval was based on clinical findings derived from a large, prospective study that was conducted at 14 sites across the US, as well as data from other supporting analytical validation studies.
“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,” Aaron Berger, MD, chief medical officer and director of Clinical Research at Associated Urological Specialists in Chicago, Illinois, stated in a news 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.”
FDA Approval of IsoPSA for High-Risk Prostate Cancer Diagnosis: Key Takeaways
The FDA has approved the IsoPSA in vitro diagnostic kit—a novel blood-based prostate cancer test—for use as an aid in the diagnosis of high-grade prostate cancer in men at least 50 years of age with elevated PSA levels.
IsoPSA evaluates structural variants of the PSA protein that are specific to prostate cancer, representing a meaningful advancement that helps physicians improve risk assessment and make more informed biopsy decisions.
Clinical and real-world utility studies of IsoPSA highlight its strong diagnostic performance, including a sensitivity rate of 90.2% for high-grade prostate cancer and a resulting 55% net decrease in biopsy recommendations among evaluated patients.
IsoPSA is designed to evaluate structural variants of the PSA protein that are specific to prostate cancer. This test allows for accurate risk assessment that can help some patients avoid unnecessary prostate biopsy, as many prostate biopsies as negative for high-risk disease.
“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,” Arnon Chait, PhD, president and chief executive officer of Cleveland Diagnostics, added in the news release. “We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide.”
The IsoPSA in vitro diagnostic kit uses the IsoClear platform, which examines the structures of protein biomarkers in the blood and uses this information to provide clinically relevant information about a patient’s disease state.
“FDA approval underscores the value and clinical utility of IsoPSA in distinguishing benign elevations of PSA from those due to high grade cancer,” Eric Klein, MD, emeritus chair of the Glickman Urological & Kidney Institute at Cleveland Clinic in Ohio and Distinguished Scientist at GRAIL, Inc., noted in the news release. “I’m very pleased to see this milestone achieved; it represents the culmination of extensive study and test development over the past decade.”
What data have been seen with the use of IsoPSA in prostate cancer?
A prospective, multicenter validation study investigated the diagnostic biomarker test in 888 patients who were scheduled for prostate biopsy.2 In this study, IsoPSA had an area under the curve of 0.783 (95% CI, 0.752-0.814) for high-grade prostate cancer. The test also had a sensitivity rate of 90.2% (95% CI, 86.4%-93.0%), a specificity rate of 45.5% (95% CI, 41.4%-49.6%), a positive predictive value rate of 47.7% (95% CI, 45.7%-49.8%), and a negative predictive value rate of 89.3% (95% CI, 85.6%-92.2%).
Additionally, in a real-world clinical utility study that enrolled 900 patients, 38 clinicians from academic and community oncology settings altered their pre-test recommendations in favor of or against biopsy and/or MRI for 66% of patients after using IsoPSA; this translated to a 55% net decrease in biopsy recommendations.
IsoPSA is included in several leading guidelines for clinical practice. Notably, the National Comprehensive Cancer Network Guidelines for Prostate Cancer Early Detection recommend the use of IsoPSA prior to biopsy and in patients with prior negative biopsy results who are considered at higher risk for clinically significant prostate cancer.
References
FDA approves IsoPSA -- Cleveland Diagnostics’ novel blood-based prostate cancer test. News release. Cleveland Diagnostics, Inc. December 1, 2025. Accessed December 1, 2025. https://www.businesswire.com/news/home/20251201324198/en/FDA-Approves-IsoPSA----Cleveland-Diagnostics-Novel-Blood-Based-Prostate-Cancer-Test
NCCN. Clinical Practice Guidelines in Oncology. Prostate cancer early detection, version 1.2026. Accessed December 1, 2025. https://www.nccn.org/professionals/physician_gls/pdf/prostate_detection.pdf
