The updated urine test utilizes machine learning and patient ethnicity to provide individualized risk scores for aggressive disease.

Trinity Biotech announced results from a clinical study of an enhanced version of its EpiCapture prostate cancer test, which is designed to provide higher precision risk prediction for aggressive forms of the disease.

This next-generation version utilizes machine learning tools that integrate patient ethnicity alongside deoxyribonucleic acid (DNA) biomarkers. This approach aims to address performance variations across different demographic and ethnic groups, as prostate cancer incidence and severity differ significantly among populations.

The EpiCapture test is a urine liquid biopsy, offering an alternative to traditional diagnostic methods such as high resolution magnetic resonance imaging scans and needle biopsies. Traditional methods can be costly, limited in availability, or carry risks of infection and other complications.

Prostate cancer is the most common non-skin cancer among men in the United States (US), with approximately 1 in 8 men diagnosed during their lifetime. US national expenditures for prostate cancer care are estimated to be over $20 billion annually. The ability to monitor disease progression is critical, as the condition is often slow-growing, and unnecessary invasive interventions can lead to complications.

Clinical Validation Results

The performance of the updated test was evaluated in a clinical study involving approximately 750 patient samples. The study was conducted independently by a bioinformatics research partner to ensure independent validation of the diagnostic performance.

Results showed a clinical accuracy (Area Under the Curve) of 85%, a level considered strong and clinically useful within the oncology diagnostics field. These data indicate the potential for the test to improve early identification of patients at risk of aggressive prostate cancer, enabling personalized care pathways.

“The enhanced EpiCapture test represents a major step forward for prostate cancer risk prediction and underscores further significant progress in our broader innovation agenda,” says John Gillard, president and chief executive officer of Trinity Biotech, in a release.

Incorporating Ethnicity into Risk Prediction

The study utilized a larger and more ethnically diverse cohort than previous evaluations of the technology. According to the company, the integration of ethnicity as a variable addresses a well-documented challenge in oncology diagnostics regarding performance variation across demographic groups.

“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,” says Antoinette Perry, PhD, associate professor in cell and molecular biology at University College Dublin, in a release. “Prostate cancer incidence and outcomes vary significantly across different geographic and ethnic populations, yet the biological drivers underlying these differences remain incompletely understood.”

Trinity Biotech plans to submit these findings for publication in a peer reviewed oncology journal. The company intends to commercialize the test as a Laboratory Developed Test through its New York State Department of Health certified diagnostics reference laboratory, allowing for the roll-out of the testing service across the US.

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