Revolutionary Blood and Urine Tests Transforming Prostate Cancer Screening

New Hope for Avoiding Unnecessary Biopsies

Major Breakthrough Could Spare Thousands of Men from Invasive Procedures While Catching Dangerous Cancers Early

A comprehensive new review published in Current Opinion in Urology reveals that cutting-edge blood and urine tests are dramatically outperforming traditional PSA screening, offering men with elevated PSA levels a powerful new way to avoid unnecessary biopsies while maintaining excellent detection of clinically significant prostate cancer.

The PSA Problem: Why We Need Better Tests

For decades, prostate-specific antigen (PSA) testing has been the cornerstone of prostate cancer screening. While PSA saves lives by detecting cancer early, its major limitation is poor specificity—meaning it often leads to unnecessary biopsies in men who don't have cancer or who have low-grade cancers that don't require treatment.

The benefits of prostate cancer screening with PSA alone are largely offset by excess negative biopsies and overdetection of indolent cancers resulting from the poor specificity of PSA for high-grade cancer, according to research published in JAMA Oncology. This has created an urgent need for better testing approaches.

Game-Changing Results from Advanced Biomarker Tests

Blood-Based Tests Leading the Way

Several blood-based biomarker tests are now showing remarkable promise:

  • Prostate Health Index (PHI): PHI was introduced by Beckman Coulter as an FDA-approved automated immunoassay for prostate cancer detection and consistently demonstrates superior performance to PSA alone.
  • 4Kscore Test: This test combines four kallikrein markers and has been endorsed by national guidelines for clinical use.
  • IsoPSA: A newer blood test that separates PSA isoforms to better distinguish between benign and cancerous conditions.

Urine-Based Tests Offering Non-Invasive Solutions

Urine tests are particularly appealing because they're completely non-invasive and can potentially be done at home:

  • MyProstateScore 2.0 (MPS2): A new urine test that measures 18 genes associated with prostate cancer provides higher accuracy for detecting clinically significant cancers than PSA and other existing biomarker tests. In validation studies, use of MPS2 would have avoided 35% to 42% of unnecessary biopsies without missing any additional diagnoses of clinically significant cancer.
  • SelectMDx: Measures two biomarkers commonly expressed in prostate cancer and is recommended by current guidelines.
  • ExoDx Prostate IntelliScore (EPI): An exosome-based urine test that has shown strong performance in clinical trials.

Groundbreaking New Research from Sweden

Scientists at Karolinska Institutet recently unveiled a breakthrough urine test that could revolutionize early detection. Using artificial intelligence, the researchers identified a set of biomarkers in urine that were able to indicate the presence and severity of prostate cancer with a high degree of precision. According to their calculations, they surpass PSA, which is the blood biomarker in current clinical use.

The study, published in Cancer Research, used digital tumor models and AI to identify proteins that can detect cancer presence and severity with remarkable accuracy. Large-scale clinical trials are being planned for the next phase of the research.

Real-World Impact: Fewer Biopsies, Better Cancer Detection

The clinical implications are profound. These assays aim to reduce the frequency of unnecessary biopsies (i.e., negative or Grade Group 1) while maintaining highly sensitive detection of clinically significant cancer (Grade Group ≥ 2) prostate cancer.

For men considering repeat biopsy after a previous negative result, the benefits are even more dramatic. The improvement was even more pronounced in men with a history of a previous negative biopsy, reducing the rate of unnecessary biopsies from 46% to 51% with use of MPS2, as compared to 9% to 21% for existing tests.

Current Guidelines and Clinical Use

The U.S. Food and Drug Administration or Clinical Laboratory Improvement Amendments have recognized tests such as 4Kscore test, Prostate Health Index (PHI), prostate-specific antigen 3 (PCA3), MyProstateScore (MPS), SelectMDx and ExoDx Prostate IntelliScore (EPI) test for clinical application, thereby offering a promising avenue for improved prostate cancer diagnosis and was recommended by NCCN and American Urological Association/Society of Urologic Oncology guidelines.

Insurance Coverage: What Patients Need to Know

Coverage for these advanced biomarker tests varies significantly by insurance type:

Medicare Coverage: Medicare plans had higher rates of coverage compared to non-Medicare plans (80% Medicare vs. 17% commercial, 15% federal employer, and 13% Medicaid).

Commercial Insurance: Of 186 insurance plans, 109 (59%) covered at least one biomarker, though prior authorization was required for 38 (35%) of 109 covering plans.

State Legislation: Several states are working to improve access. ZERO leads the charge to connect with legislatures and introduce legislation to eliminate cost-sharing for prostate cancer screening. Our bold goal is to make screening free in 25 states by 2030.

Looking Ahead: The Future of Prostate Cancer Detection

The integration of these biomarker tests represents a major step forward in personalized prostate cancer care. The MPS2 has the potential to reduce unnecessary biopsies and is therefore an important step in the right direction, according to Dr. Howard Parnes of the National Cancer Institute.

For patients, these tests offer the possibility of more confident decision-making. As one researcher noted, "In nearly 800 patients with an elevated PSA level, the new test was capable of ruling out the presence of clinically significant prostate cancer with remarkable accuracy. This allows patients to avoid more burdensome and invasive tests, like MRI and prostate biopsy, with great confidence that we are not missing something".

What This Means for IPCSG Members

For men in our support group community, these advances offer new hope and options:

  1. Better Risk Assessment: These tests can help distinguish between men who truly need immediate biopsy and those who can safely avoid it.
  2. Reduced Anxiety: More precise testing can reduce the uncertainty that comes with elevated PSA levels.
  3. Personalized Care: The tests help doctors tailor screening approaches to individual risk profiles.
  4. Quality of Life: Avoiding unnecessary biopsies means avoiding their associated risks and discomfort.

Taking Action

If you have an elevated PSA level, discuss these biomarker options with your healthcare provider. While not all tests may be covered by your insurance, many are increasingly being adopted by clinical practices. Don't let cost be a barrier to getting the best possible care—contact your insurance provider to understand your options and advocate for coverage.

The future of prostate cancer screening is becoming more precise, less invasive, and more patient-friendly. These advances represent real progress in our ongoing fight against prostate cancer.

Sources and Citations

  1. Assani, K.D., Pierce, J.M., Galloway, L.A., & Tosoian, J.J. (2025). Blood- and urine-based biomarkers for the detection of clinically significant prostate cancer: a contemporary review. Current Opinion in Urology. DOI: 10.1097/MOU.0000000000001308
  2. "Scientists Unveil Breakthrough Urine Test That Beats PSA in Spotting Prostate Cancer." SciTechDaily, May 17, 2025. https://scitechdaily.com/scientists-unveil-breakthrough-urine-test-that-beats-psa-in-spotting-prostate-cancer/
  3. "New urine test has higher diagnostic accuracy for prostate cancer." VUMC News, May 1, 2024. https://news.vumc.org/2024/04/18/new-urine-test-has-higher-diagnostic-accuracy-for-prostate-cancer/
  4. "Biomarkers in Urine Could Reduce Unnecessary Prostate Biopsies." National Cancer Institute, 2017. https://www.cancer.gov/news-events/cancer-currents-blog/2017/biomarkers-urine-prostate-biopsy
  5. Kral, M., Kurfurstova, D., Zemla, P., Elias, M., & Bouchal, J. (2025). New biomarkers and multiplex tests for diagnosis of aggressive prostate cancer and therapy management. Frontiers in Oncology, 15:1542511. https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1542511/full
  6. "An Improved Prostate Cancer Biomarker Test May Help Men Avoid Unnecessary Biopsy." National Cancer Institute Division of Cancer Prevention. https://prevention.cancer.gov/news-and-events/blog/improved-prostate-cancer-biomarker-test-may-help-men-avoid-unnecessary-biopsy
  7. "Urine test could reveal early prostate cancer." ScienceDaily, May 15, 2025. https://www.sciencedaily.com/releases/2025/04/250428220907.htm
  8. "Blood and Urine Tests for Prostate Cancer." Prostate Cancer Foundation, April 15, 2025. https://www.pcf.org/patient-support/diagnosis/blood-urine-tests/
  9. "The Present and Future of Prostate Cancer Urine Biomarkers." PMC. https://pmc.ncbi.nlm.nih.gov/articles/PMC3709804/
  10. Tosoian, J.J., et al. (2024). Development and Validation of an 18-Gene Urine Test for High-Grade Prostate Cancer. JAMA Oncology. https://jamanetwork.com/journals/jamaoncology/fullarticle/2817657
  11. "Biomarkers in prostate cancer: what's new?" PMC. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110681/
  12. "Liquid Biomarkers in Prostate Cancer Diagnosis: Current Status and Emerging Prospects." World Journal of Men's Health. https://wjmh.org/DOIx.php?id=10.5534/wjmh.230386
  13. "PSA and beyond: alternative prostate cancer biomarkers." PMC. https://pmc.ncbi.nlm.nih.gov/articles/PMC4821699/
  14. "Gene Expression Profiling and Protein Biomarkers for Prostate Cancer." South Carolina Blues. https://www.southcarolinablues.com/web/public/brands/medicalpolicy/external-policies/gene-expression-profiling-and-protein-biomarkers-for-prostate-cancer/
  15. "Early Detection of Prostate Cancer: Eliminating Costs of Screening." ZERO Prostate Cancer. https://zerocancer.org/take-action/advocate/policy-priorities/early-detection-prostate-cancer-eliminating-costs-screening
  16. "Insurance Coverage for Prostate Cancer Screening." American Cancer Society. https://www.cancer.org/cancer/types/prostate-cancer/detection-diagnosis-staging/insurance-coverage.html
  17. Marr, C., et al. (2023). Insurer coverage of prostate cancer biomarkers. Urologic Oncology: Seminars and Original Investigations. https://www.sciencedirect.com/science/article/abs/pii/S1078143923001394
  18. "Biomarkers for prostate cancer detection and risk stratification." PMC. https://pmc.ncbi.nlm.nih.gov/articles/PMC9201356/
  19. Smelik, M., et al. (2025). Combining Spatial Transcriptomics, Pseudotime, and Machine Learning Enables Discovery of Biomarkers for Prostate Cancer. Cancer Research. DOI: 10.1158/0008-5472.CAN-25-0269
  20. "Evaluation of blood and urine based biomarkers for detection of clinically-significant prostate cancer." Prostate Cancer and Prostatic Diseases, volume 28, pages 45–55 (2025). https://www.nature.com/articles/s41391-024-00840-0
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