Trinity Biotech Announces Launch of FDA-Cleared Preeclampsia Testing Service

TRIB
October 04, 2025

Trinity Biotech plc announced on August 7, 2025, the launch of a new testing service for preeclampsia, marking a significant advancement in maternal health diagnostics. The service is planned to be rolled out in Q3 2025 through Trinity Biotech’s New York-based reference laboratory. This initiative is part of a strategic collaboration with Thermo Fisher Scientific.

The company will offer the FDA-cleared PreClara Ratio (sFlt-1/PlGF) biomarker test, which provides time-sensitive, clinically actionable insights for managing hypertensive disorders of pregnancy. Preeclampsia impacts approximately 500,000 women in the United States annually and is a leading cause of maternal and neonatal complications. The test helps assess the likelihood of progression to severe preeclampsia, enabling more targeted and timely care.

Recent U.S.-based studies published in March 2025 demonstrated potential neonatal cost savings exceeding $10 million per 1,000 patients when the test is incorporated into standard care. This is primarily due to reduced preterm deliveries and neonatal intensive care unit admissions. The launch of this service also lays critical groundwork for the anticipated commercial introduction of PrePsia™, Trinity Biotech’s proprietary preeclampsia risk assessment technology designed for use in early pregnancy.

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