A new blood test, IsoPSA, recently approved by the FDA, could significantly improve prostate cancer screening and reduce the false-positive rates associated with the traditional PSA test. Developed by Cleveland Diagnostics, IsoPSA is designed to help doctors make more informed decisions about whether a prostate biopsy is necessary.
The traditional prostate-specific antigen (PSA) test measures the level of PSA in the blood, but its lack of specificity often leads to false positives. Elevated PSA levels can result from conditions unrelated to prostate cancer, such as infections or benign prostatic hyperplasia (BPH). According to the National Cancer Institute, 6% to 7% of men will have a false positive on a PSA test.
This lack of precision has significant consequences. While a tissue biopsy remains the gold standard for diagnosing prostate cancer, approximately 75% of the over one million biopsies conducted annually reveal no signs of high-grade cancer (Gleason score of 7 or higher). Though a negative biopsy result provides relief, many men endure costly and invasive procedures for no reason.
Unlike the PSA test, IsoPSA detects structural variants, or isoforms, of the PSA protein that are specific to prostate cancer. This innovative approach improves diagnostic accuracy by distinguishing benign PSA elevations from those linked to high-grade cancer.
Dr. Arnon Chait, CEO of Cleveland Diagnostics, emphasized the importance of the FDA approval, stating, “IsoPSA represents a major advancement in early cancer detection, when treatment is most effective.”
Clinical studies confirm that IsoPSA outperforms the standard PSA test and % free PSA in diagnostic accuracy. With its improved precision, the IsoPSA test helps doctors assess patient risk more reliably. It can identify those at high risk who need further intervention while sparing low-risk patients from unnecessary biopsies. One study suggests that IsoPSA could reduce unnecessary biopsies by up to 46%.
The test is easy to order, does not require a digital rectal exam, and remains accurate even for patients on medication for BPH.
IsoPSA’s inclusion in leading clinical guidelines, such as the NCCN Early Prostate Cancer Detection and the AUA/SUO Early Detection of Prostate Cancer guidelines, further underscores its significance in the evolving landscape of prostate cancer screening.
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