Trinity Biotech Launches FDA-Approved Preeclampsia Testing Service for Maternal Health

Trinity Officially Launched its FDA-approved Preeclampsia Testing Service

Announcement

Trinity Biotech plc, a leading commercial-stage biotechnology company targeting diabetes management solutions and human diagnostics, and wearable biosensors, has officially launched a new testing service for preeclampsia, a prominent advancement in maternal health diagnostics. The services will be effective in the 2025 quarter 3 via Trinity Biotech’s New York-based reference laboratory. This testing service is a relief to the maternal population and a support for pregnancy complications. The indications of this service promise a timely decision in emergency cases.

The Current Status and Requirements of the Testing

The Trinity Biotech will provide the FDA-approved Preclara ratio (sflt-1/PIGF) biomarker test as a part of the valuable partnership with Thermo Fisher Scientific, sharpening Trinity’s ability to provide complex maternal health diagnostics. An estimated 500,000 women in the United States each year are affected by hypertensive disorders of pregnancy. It’s a root cause of neonatal and maternal complications. The sflt-1/PIGF test enables clinically actionable insights and time sensitivity that helps healthcare providers in initiating informative decision-making for hospitalized patients. The assessment of recovery from extreme preeclampsia the test provides a more targeted and accurate approach in the management of care for the high-risk patient group.

The economic and clinical value of the sflt-1/PIGF test is strengthened by recent US-based studies. The publication of the research held in March 2025 elaborates the ability of neonatal cost savings flowing above by $10 million per 1,000 patients through the incorporation of the test into standard care. These savings have grounded roots in decreased preterm deliveries and admission to the neonatal intensive care unit, which spotlights economic benefit and clinical efficacy. The launch of the sflt-1/PIGF testing service holds complex groundwork for the marketing introduction of prepsia. The Trinity Biotech’s proprietary preeclampsia risk assessment technology will be used in early pregnancy cases.

Views and Statements

CEO of Trinity Biotech, John Gillard, said, “This launch demonstrates one of our essential strategic milestones in the maternal health space. This launch has prominently strengthened our position in this complex clinical area and has further helped us step forward towards transforming targeted new technology platforms in large affected areas. Our expansion of the maternal health portfolio showcases our consistency in providing value for our shareholders via innovations that identify the urgency of certain healthcare needs. As a company, we feel proud and thankful to be able to be a part of supporting patients in this significant healthcare area.”