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University Hospitals Participating In Early Evaluation of Point-of-Care PSA Test

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Innovations in Urology | Winter 2025

Prostate cancer is the second-most common cancer in men worldwide. Prior to widespread prostate specific antigen (PSA) testing, prostate cancer was often diagnosed when it had already spread or caused symptoms. At that point, it was often not curable. Early detection with PSA screening has markedly reduced prostate cancer morbidity and mortality. 

Jonathan Shoag, MDJonathan Shoag, MD

Jonathan Shoag, MD, a urologist specializing in oncology at University Hospitals Urology Institute, has just received a Phase I Small Business Innovation Research Grant from the National Cancer Institute at the National Institutes of Health, in collaboration with Chelmsford, Mass.-based Triton Systems. The grant will be used to design and evaluate an innovative, low-cost, point-of-care (POC) device, combined with a novel classifier algorithmic tool, for PSA risk assessment. They will use a large population dataset from prostate cancer patients and integrate multiple health and lifestyle factors for the detection of early-stage prostate cancer and preventive screening.

“The technology that Triton Systems developed leverages novel test detection formulations and a proprietary algorithm to interpret results and guide physicians' next steps,” Dr. Shoag says. “This is a multi-phase study that will hopefully lead to a functional prototype and a real-time classifier that organizes test results into predefined risk categories, including patient risk factors, such as age, race and family history.”

Improving Accuracy and Access

While the standard of care PSA testing methods may detect cancer earlier than it manifests clinical symptoms, and better treatments improve outcomes, there is room for improvement in screening to:

  • increase detection accuracy
  • provide more specific results to improve clinical outcomes, and
  • lower the incidence of false positives, false negatives and high rates of clinically insignificant findings.

Furthermore, the availability of current PSA testing is limited in some communities and high-risk patient groups, particularly in low-income and minority populations. The Triton detection test will address some of these access issues, making PSA screening more accessible and potentially enabling large epidemiological data collections and surveys.

Reducing Disparities

Black men and men with a family history have higher prostate cancer morbidity and mortality rates (more than double that of white men). While the reasons for these disparities are complex, most data suggest that early detection of prostate cancer in Black men — who, on average, develop prostate cancer at younger ages than white men – has the potential to markedly improve outcomes. An inexpensive, easy-to-use, point-of-care PSA screening test would make screening more accessible and easier to perform, with fewer demands on physicians and patients for blood-draws and follow ups. This is particularly important in under-resourced communities and other high-risk groups.

Involving Men in Their Own Healthcare

Triton’s detection test will use a simple finger-stick blood test men can use at home, making screening safe, easy and convenient. The results of the paper-based assay would then be fit into an algorithm integrating personal demographics, such as race and age, and offers risk classification categories men can use to help decide whether their results warrant a visit to their physician or further monitoring. Physicians will also be able to use the test during routine office visits. Dr. Shoag says the hope is that more men and their doctors will prioritize this important health screening if they have an easy testing tool.

An Alternative to Other At-home PSA Tests

“Triton’s algorithm interprets results immediately, eliminating the need for patients to send the test to a lab and await results, which can be stressful,” Dr. Shoag says. “Triton uses easy-to-understand, color-based thresholds, which allows more nuanced results and lowers the risk of false positives and false negatives, thus reducing over diagnosis and overtreatment. The paper-based, microfluidic vertical flow assay technology increases detection speed, so it’s becoming a go-to platform to obtain test results in low-resource settings.”

Dr. Shoag adds, “Ultimately, we hope to make PSA testing available to more men, especially those at high-risk, and to develop a tool that is easy to interpret, easy to use and ultimately gives us higher quality prostate cancer screening results.”

For more information about this study, contact Dr. Shoag at 440-613-4821.

Acknowledgement: This project has been funded in whole or in part with Federal funds from the National Cancer Institute, National Institutes of Health, U.S. Department of Health and Human Services, under Contract No. 75N91024C00076. Reviewed and approved in colloaboration with Triton Systems.

Contributing Expert:
Jonathan Shoag, MD
Urologist
University Hospitals Urology Institute
Associate Professor of Urology
Case Western Reserve University School of Medicine

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