Trinity Biotech plc announced that its upgraded EpiCapture prostate cancer test achieved an 85% area‑under‑the‑curve (AUC) in a 750‑sample clinical study, the highest accuracy reported for a urine liquid‑biopsy test for aggressive prostate cancer.
The study was conducted by an independent bioinformatics partner and evaluated a machine‑learning algorithm that incorporates patient ethnicity alongside DNA biomarkers, addressing known performance gaps across diverse populations. The original EpiCapture platform had a lower AUC, but the new algorithm’s inclusion of ethnicity marks a first‑in‑field improvement for biomarker tests.
Trinity plans to commercialize the test as a laboratory‑developed test (LDT) through its New York State Department of Health‑certified reference laboratory, enabling rapid U.S. market entry. The enhanced test could capture a share of the $20 billion prostate cancer care market and provide a new revenue stream while expanding the company’s precision‑oncology portfolio.
"The enhanced EpiCapture test represents a major step forward for prostate cancer risk prediction and underscores further significant progress in our broader innovation agenda. This is a strong example of how we are expanding into precision medicine and building a portfolio of advanced, multimodal, data‑driven diagnostics, including expanding the innovation capabilities of our New York reference laboratory," said President and CEO John Gillard. "The results 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," added Dr. Antoinette Perry, Associate Professor in Cell & Molecular Biology at University College Dublin.
Trinity Biotech has faced financial headwinds, including a Nasdaq delisting warning and declining revenues in some segments. The new test represents a strategic pivot into a high‑growth market and could help offset these challenges by adding a non‑invasive diagnostic option that competes with MRI and biopsy. The company’s transformation plan, which includes investment in precision‑medicine capabilities, positions the EpiCapture launch as a key milestone in its broader effort to build a portfolio of advanced, data‑driven diagnostics.
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