Trinity Biotech plc announced a new collaboration with a leading bioinformatics company to apply advanced analytical tools to the clinical trial data for its EpiCapture test, a PCR‑based epigenetic liquid biopsy that monitors the risk of prostate cancer progressing to high‑grade disease. The partnership is designed to deepen the analysis of DNA methylation patterns associated with aggressive prostate cancer, enabling more precise risk stratification and supporting the test’s progression toward regulatory approval and commercialization.
EpiCapture was acquired by Trinity in October 2024 for an initial consideration of about $3 million, with a $0.5 million milestone payment. Clinical studies published in The Journal of Clinical Oncology – Precision Oncology showed that EpiCapture, when used alongside PSA testing, correctly identified all high‑grade cancers in a prospective cohort, underscoring its clinical promise. The global prostate cancer diagnostics market is estimated at $7.7 billion to $10 billion today and is projected to exceed $11 billion by 2030, making EpiCapture a potentially high‑margin addition to Trinity’s portfolio.
Trinity has been undergoing a significant operational restructuring to address a history of operating losses and a substantial debt burden. The company has offshored manufacturing of its HIV tests and is targeting profitability and positive cash flow from operations in the second half of 2025. The EpiCapture partnership is part of this broader turnaround, offering a new revenue stream that could help offset legacy costs and accelerate the company’s return to profitability.
The collaboration is expected to accelerate the clinical development timeline and strengthen the evidence base needed for regulatory approval. By leveraging sophisticated bioinformatics, Trinity aims to demonstrate that EpiCapture can reliably identify patients at risk of disease progression, a capability that could translate into a high‑value test for clinicians and payers. Successful regulatory clearance would open a $10 billion market and provide a significant revenue upside that aligns with the company’s goal of diversifying beyond its established HbA1c and HIV diagnostics.
CEO John Gillard said the partnership “represents a strategic move into the oncology and molecular diagnostic spaces” and highlighted the company’s commitment to improving margins through operational efficiencies. He added that the offshore manufacturing of HIV tests is a milestone in Trinity’s transformation plan, expected to improve profitability and create shareholder value. These statements underscore the company’s focus on both cost discipline and high‑growth opportunities.
The partnership faces headwinds such as regulatory scrutiny—particularly the MHRA’s investigation into a positive bias in Trinity’s Premier Hb9210 HbA1c analyzer—and competition from larger diagnostics firms. However, the strong clinical data and the growing demand for liquid biopsy solutions position EpiCapture as a compelling addition to Trinity’s product line, potentially offsetting these challenges and supporting the company’s long‑term strategic objectives.
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