PSE Prostate Cancer Test is 270% Better Than PSA


This Prostate Cancer Test is 270% Better Than PSA - YouTube

Blood Test Achieves 94% Accuracy in Prostate Cancer Detection, Potentially Reducing Unnecessary Biopsies by Nearly 80%

Major breakthrough in epigenetic testing shows promise for revolutionizing PSA-based screening

By the Informed Prostate Cancer Support Group

A novel blood test combining traditional PSA screening with advanced epigenetic analysis has demonstrated 94% accuracy in detecting prostate cancer—more than doubling the reliability of PSA testing alone—according to multiple peer-reviewed studies published since 2023. The EpiSwitch Prostate Screening (PSE) test, developed through collaboration between Oxford BioDynamics PLC, Imperial College London, and the University of East Anglia, has now shown in real-world clinical settings that it could reduce unnecessary biopsies by up to 79%.

For the estimated 120,000 men in the UK and hundreds of thousands more in the United States who undergo prostate biopsies annually despite having only benign conditions, this advancement represents potentially transformative progress in addressing one of prostate cancer screening's most vexing problems: PSA's notorious lack of specificity.

The PSA Dilemma: Four Decades of Frustration

Since prostate-specific antigen testing became widespread, only about 25-35% of men with elevated PSA levels who undergo biopsy are actually found to have prostate cancer. The remainder endure an invasive procedure—involving 12 to 24 needle punctures through the perineum—with attendant risks of infection, bleeding, pain, and urinary complications, only to learn their elevated PSA stemmed from benign prostatic hyperplasia, prostatitis, physical activity, or other non-cancerous causes.

This diagnostic uncertainty has led major medical organizations to scale back PSA screening recommendations, with the test's poor specificity (ability to correctly identify those without disease) contributing to widespread concerns about overdiagnosis and overtreatment.

The problem lies in PSA's fundamental nature: PSA is not actually measuring cancer but rather a glycoprotein produced by prostate epithelial cells. Elevated levels indicate something is happening with the prostate gland, but provide no insight into what that something might be.

How Epigenetic Testing Changes the Game

The PSE test takes a fundamentally different approach by examining chromosome conformation signatures—three-dimensional structural changes in how DNA is organized within cells. These signatures represent epigenetic modifications where different parts of chromosomes fold together to create loops that enhance or suppress gene expression, and specific patterns of these conformations are associated with cancer.

The test identifies five specific epigenetic biomarkers detectable in circulating blood cells, particularly immune cells, that reflect the systemic changes associated with prostate cancer development. Importantly, factors that commonly produce false-positive PSA results—including infection, inflammation, recent intimacy, prostate size, and heavy exercise—do not affect the epigenetic markers measured by the PSE test.

Dr. Dmitry Pshezhetskiy, who led the research team at the University of East Anglia's Norwich Medical School, explained the test's significance: "For the first time our study demonstrates that combining epigenetic testing with the already well-established PSA test allows for a much more accurate diagnosis of prostate cancer. The new test has the potential to reduce the number of unnecessary biopsies and MRIs, which would both prevent anxiety and complications, and also deliver huge cost savings to health services."

Clinical Validation: From Research to Real-World Practice

The PSE test's journey from laboratory concept to clinical reality has involved multiple validation studies with increasingly robust evidence.

Initial Studies (2023): The foundational research published in the journal Cancers evaluated 147 patients across two cohorts—109 from the PROSTAGRAM screening study and 38 from an Imperial College study. When PSA was used with a traditional 3.0 ng/mL cutoff, it showed a positive predictive value of only 0.14. Adding the epigenetic markers increased this to 0.81, and when PSA was integrated as a continuous variable rather than a simple cutoff, the combined PSE test achieved a positive predictive value of 0.92 and negative predictive value of 0.94.

Performance Characteristics: Independent validation demonstrated the test has 86% sensitivity (correctly identifying 9 out of 10 men with prostate cancer) and 97% specificity (correctly identifying more than 19 out of 20 men without cancer as cancer-free).

Real-World Evidence (2024-2025): The most recent study, published in mid-2025, evaluated 187 patients in routine urology practice settings. Using predictive modeling on 134 patients without biopsies, researchers found that 79.1% could have safely deferred biopsy based on low-likelihood PSE results, while an alternative model showed 66.4% could have avoided biopsy. This real-world data, collected from practicing urologists rather than controlled research settings, provides particularly compelling evidence of the test's practical utility.

Clinical Implementation and Workflow Integration

The test requires a standard blood draw into K2-EDTA tubes, can be stored at room temperature, and ships overnight to the laboratory with no specialized handling. Samples are processed within 48 hours, and results are typically available within 5 days.

The clinical pathway works as follows: Men with elevated PSA or abnormal digital rectal examination receive the PSE test. Those with low-likelihood results may be monitored with repeat testing in one year, avoiding immediate MRI and biopsy. High-likelihood results trigger multiparametric MRI and, if indicated, MRI-guided or systematic biopsy for definitive diagnosis.

In the United States, the test is performed in a CLIA-certified laboratory under reimbursement code CPT PLA 0433U. In the United Kingdom, BUPA covers PSE tests run by UKAS-accredited clinical laboratories.

Commercial Availability and Current Limitations

Oxford BioDynamics launched the PSE test for UK patients in January 2024, initially targeting the private healthcare market and concierge medicine sector in the United States. The test is not currently available through the NHS, primarily due to cost considerations and the need for additional validation across diverse patient populations.

Private testing costs approximately £750 (roughly $950 USD), placing it beyond the reach of many patients and representing a significant barrier to widespread adoption. This price point reflects the sophisticated laboratory processes involved in 3D genomic profiling but remains a obstacle to equitable access.

The company is currently conducting the PROWES registry study to generate real-world uptake data and support inclusion in clinical practice guidelines.

Who Should Consider the PSE Test?

The test may be particularly valuable for several clinical scenarios: men aged 45-75 who have never had PSA testing and are in high-risk demographics (such as men of African descent or those with family history of prostate, breast, or ovarian cancer); men with mildly elevated PSA where additional accuracy could prevent unnecessary procedures; patients with elevated PSA and equivocal MRI results (score 3) to determine if biopsy is needed; cases where PSA and MRI are abnormal but biopsy shows no cancer, suggesting possible sampling error; and situations where PSA remains elevated despite negative previous testing.

Broader Context: The Epigenetics Revolution in Prostate Cancer

The PSE test represents just one application of the rapidly expanding field of cancer epigenetics. Recent research has identified that epigenetic alterations—including DNA methylation, histone modifications, and chromatin remodeling—play crucial roles throughout the entire spectrum of prostate cancer, from initiation through progression to castration resistance and neuroendocrine transdifferentiation.

Other epigenetic tests under development include the Prostate Cancer Urinary Epigenetic (ProCUrE) assay, which uses DNA methylation of the HOXD3 and GSTP1 genes in urine samples to detect clinically significant prostate cancer. Oxford BioDynamics has also reported promising results for a colorectal cancer blood test achieving 81% accuracy for early-stage detection and 82% accuracy for detecting precancerous polyps.

The growing understanding of how epigenetic modifications silence tumor-suppressor genes, activate oncogenic drivers, and contribute to therapy resistance has positioned epigenetic markers as promising targets not only for diagnosis but also for novel therapeutic interventions.

Critical Evaluation: Questions That Remain

Despite the encouraging data, several important limitations and unanswered questions deserve consideration:

Population Diversity: The validation studies to date have primarily involved European populations. Performance across different ethnic groups—particularly men of African descent who face higher prostate cancer incidence and mortality—requires specific validation given well-documented differences in both genetic and epigenetic profiles across populations.

Long-term Outcomes: While the test demonstrates high accuracy in identifying current cancer presence, longer-term follow-up studies are needed to confirm that men with low-likelihood results who defer biopsy do not experience delayed diagnosis of clinically significant cancers.

Aggressive vs. Indolent Disease: The test's ability to distinguish between aggressive cancers requiring immediate treatment and indolent cancers suitable for active surveillance requires further clarification. The real-world study data suggests the test performs better at identifying higher-grade disease (Gleason ≥3+4), but more work is needed to define optimal clinical decision thresholds.

Cost-Effectiveness: While potentially reducing unnecessary biopsies, comprehensive health economic analyses comparing PSE-guided care to current standard practices across different healthcare systems have not yet been published.

Regulatory Status: The test does not currently have FDA approval in the United States for marketing as a diagnostic device, operating instead under the Clinical Laboratory Improvement Amendments (CLIA) framework. Full FDA clearance or approval would require additional prospective clinical trials.

Expert Perspectives and Clinical Implications

Leading urologists have expressed cautious optimism about the technology. Mathias Winkler, Consultant Urologist at Charing Cross Hospital and Imperial College London, stated: "By avoiding a biopsy, men avoid the inconvenience, pain and anxiety of an invasive procedure, as well as the risks involved. There is also a cost saving to the health service. We hope this test will become a standard component in the prostate cancer diagnostic pathway."

The test's integration into clinical practice could fundamentally reshape prostate cancer screening strategies. Traditional PSA testing shows a positive predicted value of only 0.14 and negative predicted value of 0.93 at the standard 3.0 ng/mL cutoff. By more than tripling the positive predictive value while maintaining high negative predictive value, the PSE test could make screening programs significantly more acceptable to both patients and healthcare systems.

Recommendations for IPCSG Members

For members of our support group considering prostate cancer screening or already navigating diagnostic uncertainty, the following guidance seems prudent:

  1. Continue Standard Care: Until the PSE test receives broader validation, regulatory approval, and insurance coverage, men should continue following established screening guidelines based on individual risk factors and in consultation with their physicians.

  2. Consider PSE for Specific Situations: Men facing decisions about biopsy after elevated PSA or equivocal MRI results might discuss with their urologists whether PSE testing could provide additional clinically useful information, understanding that out-of-pocket costs may be substantial.

  3. High-Risk Populations: Men of African descent and those with strong family histories should be aware that while the test shows promise, specific validation in diverse populations is still evolving.

  4. Stay Informed: As additional research emerges and regulatory pathways progress, we will continue providing updates through this newsletter.

  5. Ask About Clinical Trials: Men who are candidates for screening might inquire whether clinical trials evaluating the PSE test or other novel diagnostics are available at their institutions.

The Path Forward

The development of the PSE test exemplifies how advances in our understanding of cancer biology—particularly the recognition that epigenetic changes often precede and drive genetic mutations—are being translated into practical clinical tools. Oxford BioDynamics has compiled what they describe as the world's largest 3D genomic database across more than 30 disease areas, providing a foundation for developing additional diagnostic tests.

The coming years will likely see continued refinement of the test, expansion into broader populations, integration with artificial intelligence to enhance interpretation, and combination with other emerging technologies such as PSMA PET imaging and multi-parametric MRI.

For now, the PSE test represents an important proof of concept: that examining the molecular machinery of cancer at the epigenetic level can provide clinically meaningful information that simple protein measurements cannot. While significant work remains before this becomes part of standard care, the progress to date offers genuine hope for improving the accuracy of prostate cancer detection while reducing the burdens of overdiagnosis and unnecessary intervention.

As members of the Informed Prostate Cancer Support Group, we understand the anxiety that accompanies diagnostic uncertainty and the relief that comes from accurate information. The PSE test, though still evolving, moves us closer to the goal we all share: detecting dangerous cancers early while sparing men with benign conditions from needless worry and invasive procedures.

References and Sources

Primary Research Studies on the PSE Test:

  1. Pchejetski D, Hunter E, Dezfouli M, Salter M, et al. Circulating Chromosome Conformation Signatures Significantly Enhance PSA Positive Predicting Value and Overall Accuracy for Prostate Cancer Detection. Cancers. 2023;15(3):821. doi:10.3390/cancers15030821. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC9913359/

  2. Abdo J, Mathis R, Berghausen J, Pohlman T, Hunter E, Akoulitchev A. EpiSwitch PSE Blood Test Reduces Unnecessary Prostate Biopsies: A Real-World Clinical Utility Study. Cancers. 2025;17(13):2193. doi:10.3390/cancers17132193. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC12249354/

  3. University of East Anglia. "The new prostate cancer blood test with 94 per cent accuracy." ScienceDaily, February 8, 2023. Available at: https://www.sciencedaily.com/releases/2023/02/230207191546.htm

News and Clinical Implementation:

  1. Fricker J. New prostate cancer blood test combining PSA with epigenetic test could reduce biopsies. Cancer World. April 17, 2024. Available at: https://cancerworld.net/new-prostate-cancer-blood-test-psa-epigenetic/

  2. Top Doctors UK. PSE test: What is it, and is it accurate? December 13, 2024. Available at: https://www.topdoctors.co.uk/medical-articles/what-is-a-pse-test-and-how-accurate-is-it/

  3. PharmaTimes. Oxford Biodynamics launches prostate screening test. January 10, 2024. Available at: https://pharmatimes.com/news/oxford_biodynamics_launches_prostate_screening_test_1501004/

  4. Front Line Genomics. New blood test for prostate cancer shows 94% accuracy. February 9, 2023. Available at: https://frontlinegenomics.com/new-blood-test-for-prostate-cancer-shows-94-accuracy/

Commercial and Technical Information:

  1. Oxford BioDynamics PLC. EpiSwitch Prostate Cancer Detection (PSE) Test. Available at: https://www.94percent.com/

  2. Oxford BioDynamics PLC. Products & Services. Available at: https://www.oxfordbiodynamics.com/products-services

  3. Oxford BioDynamics PLC. EpiSwitch Platform. Available at: https://www.oxfordbiodynamics.com/episwitch-platform

Epigenetic Biomarkers in Prostate Cancer - General Background:

  1. Haldrup C, Okello JBA, Sommer M, et al. Prostate cancer epigenetics — from pathophysiology to clinical application. Nature Reviews Urology. January 16, 2025. doi:10.1038/s41585-024-00991-8. Available at: https://www.nature.com/articles/s41585-024-00991-8

  2. Agbetuyi-Tayo P, Gbadebo M, Rotimi OA, Rotimi SO. Advancements in Biomarkers of Prostate Cancer: A Review. Technology in Cancer Research & Treatment. 2024. doi:10.1177/15330338241290029. Available at: https://journals.sagepub.com/doi/10.1177/15330338241290029

  3. Jerónimo C, Bastian PJ, Bjartell A, et al. Epigenetics in prostate cancer: biologic and clinical relevance. European Urology. 2011;60(4):753-766. doi:10.1016/j.eururo.2011.06.035

  4. Van Neste L, Herman JG, Otto G, et al. The epigenetic promise for prostate cancer diagnosis. Prostate. 2012;72(11):1248-1261. doi:10.1002/pros.22459

  5. Hussain MS, Khan Y, Maqbool M, et al. Epigenetic alterations in prostate cancer: the role of chromatin remodeling. Expert Opinion on Therapeutic Targets. July 22, 2025. doi:10.1080/17501911.2025.2535938. Available at: https://pubmed.ncbi.nlm.nih.gov/40694614/

  6. Sharma B, Shekhar H, Sahu A, et al. Epigenetic insights into prostate cancer: exploring histone modifications and their therapeutic implications. Frontiers in Oncology. 2025;15:1570193. doi:10.3389/fonc.2025.1570193. Available at: https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1570193/full

  7. Rafikova G, Gilyazova I, Enikeeva K, et al. Prostate Cancer: Genetics, Epigenetics and the Need for Immunological Biomarkers. International Journal of Molecular Sciences. 2023;24(16):12797. doi:10.3390/ijms241612797. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC10454494/

PSA Testing and Current Screening Guidelines:

  1. Grossman DC, Curry SJ, Owens DK, et al. Screening for Prostate Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2018;319(18):1901-1913. doi:10.1001/jama.2018.3710

  2. Loeb S, Bjurlin MA, Nicholson J, et al. Overdiagnosis and overtreatment of prostate cancer. European Urology. 2014;65(6):1046-1055. doi:10.1016/j.eururo.2013.12.062

  3. Ilic D, Djulbegovic M, Jung JH, et al. Prostate cancer screening with prostate-specific antigen (PSA) test: a systematic review and meta-analysis. BMJ. 2018;362:k3519. doi:10.1136/bmj.k3519

Related Commercial Developments:

  1. Trinity Delta. Oxford BioDynamics investment research. January 15, 2025. Available at: https://www.trinitydelta.org/companies/oxford-biodynamics/

  2. Business Wire. Oxford BioDynamics' EpiSwitch CRC Blood Test Accurately Detects both Cancer and Polyps. February 5, 2025. Available at: https://www.businesswire.com/news/home/20250204025778/en/Oxford-BioDynamics-EpiSwitch-CRC-Blood-Test-Accurately-Detects-both-Cancer-and-Polyps

Additional Resources:

For the most current information on the PSE test and ongoing clinical trials, readers may search:

  • PubMed (https://pubmed.ncbi.nlm.nih.gov/) using terms: "EpiSwitch PSE", "prostate epigenetic biomarkers", "chromosome conformation prostate cancer"
  • ClinicalTrials.gov (https://clinicaltrials.gov/) for active studies involving epigenetic prostate cancer testing
  • Oxford BioDynamics corporate website (https://www.oxfordbiodynamics.com) for commercial availability updates

This article is intended for educational purposes and should not be considered medical advice. All screening and diagnostic decisions should be made in consultation with qualified healthcare providers. The Informed Prostate Cancer Support Group has no financial relationship with Oxford BioDynamics or any commercial entity discussed in this article.

 

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