FDA Approves IsoPSA Blood Test to Detect Prostate Cancer

The FDA approved a blood-based test, IsoPSA (Cleveland Diagnostics, Inc.), to evaluate prostate cancer-specific structural variants of the PSA protein in men 50 years of age and older. The test serves as an aid in the decision for prostate biopsy for men who have elevated PSA levels.¹

“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, company president and CEO, said in a news release. “We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide.”¹

Prostate cancer is the second most common cancer in American men, in which about 1 in 8 are diagnosed during their lifetime. In the US, more than 1 million men will undergo prostate biopsies each year; however, up to 75% of those follow-up tests are negative for high-grade disease. This diagnostic gap can subject millions of patients to invasive, costly procedures that can produce physical risks, emotional stress, and significant health care costs.¹

IsoPSA helps close this gap, giving health care professionals and patients a more accurate risk assessment and greater confidence in biopsy decision-making. It is an in vitro diagnostic blood test kit that helps determine if high PSA in a patient is due to cancer, and with those results, patients—in collaboration with health care professionals—can decide whether they are in need of a prostate biopsy. Although elevated PSA is often due to prostate cancer, noncancerous factors such as an enlarged prostate, infections, or physical activity may also be factors of elevated PSA.^1,2

“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, said in the 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.”¹

The blood test’s efficacy has been supported by findings in clinical research and through case studies. One such study is a prospective, multicenter study published in Urologic Oncology in 2022. It determined there was a 35.6% prevalence of high-grade prostate cancer risk and a 58.9% prevalence of any prostate cancer risk in patients receiving the test. Additionally, the area under the receiver operating characteristic curve was 0.783 (high-grade) and 0.770 (any).

Of note, IsoPSA was observed to outperform total PSA and % free PSA on area under the receiver operating characteristic curve, specificity, positive and negative predictive value at similar sensitivity, and an estimated 46% (high-grade) and 42% (any) of biopsies could be avoided in low-risk patients. The test also maintained accuracy in clinically relevant subgroups.³

“FDA approval underscores the value and clinical utility of IsoPSA in distinguishing benign elevations of PSA from those due to high grade cancer,” said Eric Klein, Emeritus Chair of the Glickman Urological & Kidney Institute at Cleveland Clinic and distinguished scientist at GRAIL, Inc, said 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.”¹

REFERENCES
1. BioSpace. FDA Approves IsoPSA® -- Cleveland Diagnostics’ Novel Blood-Based Prostate Cancer Test. News release. December 1, 2025. Accessed December 2, 2025. https://www.biospace.com/press-releases/fda-approves-isopsa-cleveland-diagnostics-novel-blood-based-prostate-cancer-test

2. IsoPSA. Accessed December 2, 2025. https://www.isopsa.com/

3. Klein EA, Partin A, Lotan Y, et al. Clinical validation of IsoPSA, a single parameter, structure-focused assay for improved detection of prostate cancer: A prospective, multicenter study. Urol Oncol. 2022;40(9):408.e9-408.e18. doi:10.1016/j.urolonc.2022.06.002