Urine Based Test for Prostate Cancer

Value Proposition

·      Non-invasive prostate cancer detection: A urine-based biomarker panel may enable identification of prostate cancer without the discomfort, risk, or logistical burden of an invasive biopsy.

·      Improved diagnostic accuracy: Early data show strong sensitivity and specificity for detecting prostate cancer, supporting the potential for more reliable screening and triage of patients with elevated PSA.

·      Clinical utility for risk stratification: The test may help distinguish men who are more likely to harbor clinically significant disease, potentially reducing unnecessary biopsies and improving care pathways.

Unmet Need

Prostate cancer remains one of the most commonly diagnosed cancers in men, yet current screening and diagnostic approaches have important limitations. PSA testing lacks specificity and can lead to false positives, unnecessary anxiety, and avoidable biopsies. There is a clear need for a non-invasive, accurate, and clinically practical test that can better identify men at risk for prostate cancer and support more informed decisions about follow-up evaluation.

Technology Description

Johns Hopkins investigators have developed a multi-analyte urine biomarker panel for the detection of prostate cancer. The assay measures a set of molecular features present in urine that are associated with prostate malignancy, leveraging the fact that prostate-derived biological material can be captured non-invasively after prostatic secretion into the urinary tract.

The published work describes a biomarker-driven diagnostic approach in which candidate markers were identified and combined into a panel to improve classification performance compared with any single marker alone. This type of multiplex design is intended to increase both sensitivity and specificity by integrating complementary signals from prostate cancer-associated molecules in urine. In the reported study, the panel showed strong diagnostic performance for identifying prostate cancer, including clinically meaningful accuracy in distinguishing affected from unaffected individuals.

The technology is compatible with standard urine collection, which supports straightforward sample acquisition and broad clinical usability. Because the assay is urine-based rather than tissue-based, it has the potential to serve as a triage or adjunct test for men with elevated PSA, equivocal findings, or other indications for further evaluation. The platform is also supported by a published patent application (WO 2023/108166), underscoring its novelty and translational potential.

Stage of Development

The technology has been reported in peer-reviewed literature and highlighted in institutional and media coverage. Additional validation, optimization, and development steps may be required before broad clinical deployment or commercialization.

Data Availability: Data available upon request.

Publications:

1.     Yuan, Menglang, et al. "A sensitive and specific non-invasive urine biomarker panel for prostate cancer detection." EBioMedicine 119 (2025).

2.     Published Patent Application: WO 2023/108166

3.     Johns Hopkins Investigators Create New Urine-based Test to ID Prostate Cancers | Johns Hopkins Medicine

4.     Urine-based test detects prostate cancer with 91% accuracy: Johns Hopkins - Becker's Oncology

5.     https://www.renalandurologynews.com/features/urine-test-prostate-cancer-detection/

Urine-Based Biomarker Panel for the Detection of Prostate Cancer - The ASCO Post