Trinity Biotech plc, a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced that this week, its New York, reference laboratory has received regulatory approval from the New York State Department of Health (NYSDOH) to begin providing the FDA-cleared PreClara™ Ratio (sFlt-1/PlGF) biomarker test for preeclampsia risk assessment. The service is planned to be rolled out in Q3 2025.

This approval marks a significant milestone in Trinity Biotech’s maternal health strategy and strengthens its position in the U.S. diagnostics market. The PreClara™ test provides clinicians with time-sensitive, clinically actionable insights to support informed decision-making for patients hospitalised with hypertensive disorders of pregnancy. Approximately 500,000 women in the United States are affected annually by hypertensive pregnancy disorders, a leading cause of maternal and neonatal complications. The PreClara™ Ratio test helps assess the likelihood of progression to severe preeclampsia, enabling more targeted and timely care for this high-risk population. Recent U.S.-based studies published in March 2025 demonstrated potential neonatal cost savings exceeding $10 million per 1,000 patients¹ when the test is incorporated into standard care, primarily through reduced preterm deliveries and NICU admissions.

The NYSDOH approval of the sFlt-1/PlGF testing service further lays critical groundwork for the anticipated commercial introduction of PrePsia™, Trinity Biotech’s proprietary preeclampsia risk assessment technology designed for use in early pregnancy.