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Data demonstrates that IsoPSA Test is more specific to csPCA.
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Improve Diagnostic Specificity for Better Biopsy Decisions
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When evaluating prostate cancer risk, the diagnostic challenge is not just detection but risk stratification: PSA testing often fails to distinguish between benign conditions and clinically significant disease.
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Clinical data1 shows that the IsoPSA Test outperforms PSA testing in specificity for clinically significant disease:
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>2x specificity vs. total PSA (tPSA)
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>3x specificity vs. %free PSA
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Unlike PSA testing, which only measures PSA concentration, the IsoPSA Test also analyzes structural PSA isoforms associated with cancer. This approach provides the clarity to help identify high-risk patients who would benefit from a biopsy while also potentially reducing unnecessary procedures for low-risk patients.
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Earn CME & Deepen Your Clinical Knowledge
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To see how this data on the IsoPSA Test accuracy translates into clinical practice, we invite you to a presentation by Dr. Aaron Berger, Chief Medical Officer of Associated Urological Specialists, on “Guiding Prostate Cancer Diagnosis with Biomarker Testing.”
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This program is designed to help you evaluate ancillary testing for prostate cancer for your practice. Dr. Berger discusses how these tests, including the IsoPSA Test, can help:
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Assess cancer risk with greater accuracy
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Guide monitoring and biopsy decisions with more confidence
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Support shared decision-making and patient-centered care
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Klein, et al., Urol Oncol. 2022 Sep;40(9):408.e9-408.e18.
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This material concerns the IsoPSA Test, a laboratory developed test (LDT) from Cleveland Diagnostics, Inc., which is performed by CLIA-certified laboratories qualified to conduct high-complexity clinical testing and is only intended for use consistent with applicable CLIA requirements. When offered as an LDT, the IsoPSA Test has not been cleared or approved by the U.S. Food and Drug Administration (FDA).
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