The U.S. Food and Drug Administration (FDA) has approved the IsoPSA in vitro diagnostic kit, a novel blood-based test designed to aid in diagnosing high-grade prostate cancer in men aged 50 and older with elevated prostate-specific antigen (PSA) levels. The approval followed the FDA’s premarket review process.
The decision was based on results from a large, prospective study conducted at 14 U.S. sites, supported by additional analytical validation studies.
“As a practicing urologist, I see firsthand how the limitations of current PSA testing can lead to unnecessary procedures and patient anxiety,” said Dr. Aaron Berger, chief medical officer at Associated Urological Specialists in Chicago. “IsoPSA represents a meaningful advancement, giving physicians a tool to improve risk assessment and make biopsy decisions with greater confidence.”
IsoPSA evaluates structural variants of the PSA protein that are specific to prostate cancer, allowing for more precise risk assessment. By distinguishing between benign PSA elevations and high-grade disease, the test may help some patients avoid unnecessary prostate biopsies.
“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,” said Arnon Chait, PhD, president and CEO of Cleveland Diagnostics. “We are focused on expanding access to IsoPSA nationwide.”
The test uses the IsoClear platform, which analyzes protein biomarker structures in blood to provide clinically relevant information about a patient’s disease state.
“FDA approval underscores the clinical value of IsoPSA in distinguishing benign PSA elevations from high-grade cancer,” said Dr. Eric Klein, emeritus chair of the Glickman Urological & Kidney Institute at Cleveland Clinic. “This milestone reflects a decade of research and development.”
Clinical Data
A multicenter validation study of 888 patients scheduled for prostate biopsy found IsoPSA achieved an area under the curve of 0.783 for high-grade prostate cancer. The test demonstrated 90.2% sensitivity, 45.5% specificity, a positive predictive value of 47.7%, and a negative predictive value of 89.3%.
In a separate real-world clinical study of 900 patients, 38 clinicians reported that IsoPSA results led to changes in biopsy or MRI recommendations for 66% of patients, resulting in a 55% net reduction in biopsy recommendations.
IsoPSA is also included in major clinical guidelines. The National Comprehensive Cancer Network (NCCN) recommends IsoPSA use prior to biopsy and in patients with a prior negative biopsy who are at higher risk for clinically significant prostate cancer.
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