Trinity Biotech Launches FDA-Cleared Preeclampsia Testing Service in Q3 2025

Trinity Biotech is launching a new testing service for preeclampsia, a serious condition affecting pregnant women, in Q3 2025 through its reference laboratory in New York. The service will use the FDA-cleared PreClara Ratio biomarker test, a strategic collaboration with Thermo Fisher Scientific, providing timely and actionable insights for healthcare providers.

Title: Trinity Biotech Launches New Preeclampsia Testing Service

Trinity Biotech plc has announced the launch of a new testing service for preeclampsia, a significant advancement in maternal health diagnostics. The service is planned to be rolled out in the third quarter of 2025 through Trinity Biotech's New York-based reference laboratory. This initiative is part of a strategic collaboration with Thermo Fisher Scientific, enhancing Trinity Biotech's capabilities to deliver critical maternal health diagnostics.

The service will offer the FDA-cleared PreClara Ratio (sFlt-1/PlGF) biomarker test, which provides time-sensitive, clinically actionable insights for healthcare providers. By helping to assess the likelihood of progression to severe preeclampsia, the test enables more targeted and timely management of care for this high-risk patient population. Approximately 500,000 women in the United States are impacted by hypertensive disorders of pregnancy each year, making this a leading cause of maternal and neonatal complications [1].

The PreClara Ratio (sFlt-1/PlGF) is intended for use in conjunction with other laboratory tests and clinical assessments to aid in the risk assessment of pregnant women (singleton pregnancies between 23+0 and 34+6/7 weeks gestation) hospitalized for hypertensive disorders of pregnancy for progression to preeclampsia with severe features within two weeks of presentation [2].

The clinical and economic value of the sFlt-1/PlGF test is reinforced by recent U.S.-based studies. Research published in March 2025 demonstrated potential neonatal cost savings exceeding $10 million per 1,000 patients when the test is incorporated into standard care. These savings primarily stem from reduced preterm deliveries and neonatal intensive care unit admissions, highlighting both clinical efficacy and economic benefit [2].

Trinity Biotech's CEO, John Gillard, stated that the launch of the sFlt-1/PlGF testing service lays critical groundwork for the anticipated commercial introduction of PrePsia™, Trinity Biotech's proprietary preeclampsia risk assessment technology designed for use in early pregnancy [2].

This strategic milestone reflects Trinity Biotech's commitment to delivering value to shareholders through innovations that address urgent healthcare needs. The company is proud to be part of supporting patients in this important healthcare area [2].

References
[1] https://www.marketscreener.com/news/trinity-biotech-plc-announces-launch-of-fda-cleared-preeclampsia-testing-service-ce7c5edfd08cf32c
[2] https://finance.yahoo.com/news/trinity-biotech-announces-launch-fda-120000059.html