Trinity Biotech plc announced a strategic collaboration with a leading bioinformatics company to conduct advanced analysis on clinical trial data for EpiCapture, the company's PCR-based epigenetic liquid biopsy test for monitoring the risk of prostate cancer progressing to more aggressive forms of the disease. The collaboration will apply sophisticated bioinformatics tools to enhance the depth of analysis and support the continued development of the test.
Non-Invasive Monitoring Technology
The EpiCapture test offers a non-invasive method to monitor disease progression by detecting DNA methylation patterns associated with high-grade prostate cancer. This approach addresses a critical clinical need, as many patients currently undergo repeated invasive procedures, such as prostate biopsies, which carry risks including infection, bleeding, and urinary complications.
The collaboration supports the advancement of the EpiCapture test, which is currently in late-stage development, toward regulatory approval and commercialization. This initiative is part of Trinity Biotech's broader strategy to expand the company's portfolio of innovative, clinically impactful technologies.
Addressing Significant Disease Burden
Prostate cancer represents a substantial clinical and economic challenge, being the most common non-skin cancer among men in the U.S., with about 1 in 8 men diagnosed during their lifetime. The cost for diagnosis and treatment is estimated at over approximately $10 billion annually.
Because prostate cancer can often progress slowly, accurate monitoring is essential. The approval and adoption of a reliable, non-invasive test like EpiCapture could help reduce unnecessary interventions and improve patient care.
Clinical Validation Results
A study published in The Journal of Clinical Oncology – Precision Oncology demonstrated that EpiCapture correctly predicted all high-grade cancers when used alongside the widely adopted PSA test. These findings support the test's potential to improve clinical decision-making and patient outcomes.
Trinity Biotech will continue to leverage its diagnostic expertise and New York State certified reference laboratory to support EpiCapture's development and prepare for regulatory submission and commercialization. The company is a commercial-stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors.
