Announcement • Mar 25
Trinity Biotech Plc Announces Successful Clinical Results For Enhanced Epicapture Prostate Cancer Test
Trinity Biotech plc announced successful results from a clinical study of a new, enhanced version of its EpiCapture prostate cancer test, engineered to deliver higher precision risk prediction of aggressive prostate cancer. This next-generation version of EpiCapture utilizes machine learning tools that integrate additional patient features, including patient ethnicity in conjunction with the DNA biomarkers, enabling the test to generate more accurate, individualized risk prediction scores. This enhanced approach addresses a well-documented challenge in oncology diagnostics: meaningful performance variation across different demographic and ethnic groups, particularly in prostate cancer where incidence and severity differ significantly among populations. EpiCapture, as a urine liquid biopsy test, offers a simpler and more accessible alternative to traditional diagnostic methods for assessing high-grade prostate cancer risk. Current approaches — including high resolution MRI scans, which are often costly and limited in availability, and needle biopsies, which may expose patients to infection risk and other complications — present significant barriers to early and accessible detection. Prostate cancer is the most common non-skin cancer among men in the U.S., with about 1 in 8 men diagnosed during their lifetime and U.S. national expenditures for prostate cancer care recently estimated to be over $20 billion annually. The ability to accurately monitor prostate cancer progression is critical, as the disease can often be slow-growing, and unnecessary invasive interventions, such as prostate biopsies, can lead to significant complications. The performance of the upgraded test was evaluated in a comprehensive clinical study involving approximately 750 patient samples, representing a substantially larger and more ethnically diverse cohort than EpiCapture’s earlier studies. The study was conducted independently by a specialist bioinformatics research partner, to ensure rigorous and independent validation of the diagnostic performance obtained with the next-generation EpiCapture algorithm. Results from this latest study indicate that the new version of the EpiCapture test delivers clinical accuracy (Area Under the Curve, AUC) of 85%—a level considered strong and clinically useful within the oncology diagnostics field. These data underscore the potential of EpiCapture to improve early identification of patients at risk of aggressive prostate cancer, enabling more informed clinical decision making and personalized care pathways. These findings will now be submitted for publication in a peer reviewed oncology journal. Trinity Biotech plans to commercialize the EpiCapture test as a proprietary Laboratory Developed Test (LDT) through its New York State Department of Health certified diagnostics reference laboratory. This strategy allows for the rapid roll-out of this precision oncology testing service to patients across the U.S. EpiCapture marks Trinity Biotech’s first entry into the precision oncology diagnostics market, representing a significant milestone in the Company’s strategic evolution toward precision medicine applications. The development of the enhanced EpiCapture test reflects Trinity Biotech’s commitment to leveraging its scientific expertise, bioinformatics capabilities, and clinical infrastructure to address unmet needs in high burden disease areas. The results of this multi-centre study demonstrate strong performance and establish the technology as a first-in-field biomarker test to incorporate ethnicity as a key variable within its predictive algorithm. Prostate cancer incidence and outcomes vary significantly across different geographic and ethnic populations, yet the biological drivers underlying these differences remain incompletely understood. 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