Trinity Biotech’s Enhanced EpiCapture Test Achieves 85% AUC in 750-Sample Study
Trinity Biotech’s enhanced EpiCapture prostate cancer test delivered clinical accuracy (AUC) of 85% in a 750-sample study using a new machine learning algorithm incorporating patient ethnicity. The company plans to commercialize the test as a Laboratory Developed Test through its New York State certified reference lab.
1. Clinical Validation Demonstrates High Accuracy
The upgraded EpiCapture test was evaluated across 750 patient samples in a multicenter clinical study with an ethnically diverse cohort, achieving an Area Under the Curve of 85% for aggressive prostate cancer risk prediction.
2. Machine Learning Algorithm Integrates Ethnicity
A new machine learning algorithm integrates DNA biomarkers with patient features such as ethnicity to deliver individualized risk scores and address diagnostic performance variability among demographic groups.
3. Commercialization as Laboratory Developed Test
Trinity Biotech plans to offer the enhanced EpiCapture test as a Laboratory Developed Test through its New York State certified reference lab, enabling rapid nationwide access.
4. Strategic Entry into Precision Oncology Market
This launch marks Trinity Biotech’s first entry into the precision oncology diagnostics market, advancing its strategic shift toward multimodal, data-driven testing solutions for high-burden diseases.