Trinity Biotech launches FDA-cleared preeclampsia test service

Trinity Biotech plc (NASDAQ: TRIB) announced the launch of a testing service for preeclampsia through its New York-based reference laboratory. The service is scheduled to roll out in the third quarter of 2025.

The company will offer the FDA-cleared PreClara Ratio (sFlt-1/PlGF) biomarker test through a collaboration with Thermo Fisher Scientific. The test is designed to assess the risk of progression to severe preeclampsia in hospitalized pregnant women between 23 and 34 weeks of gestation who have hypertensive disorders of pregnancy.

Preeclampsia affects approximately 5-8% of pregnancies and accounts for about 11% of maternal deaths and 15% of premature births in the United States. The condition impacts roughly 500,000 women annually in the country.

"This launch represents an important strategic milestone in Trinity Biotech's maternal health strategy, significantly enhancing our position in this critical clinical area," said John Gillard, CEO of Trinity Biotech.

Research published in March 2025 indicated potential neonatal cost savings exceeding $10 million per 1,000 patients when the test is incorporated into standard care. The savings stem primarily from reduced preterm deliveries and neonatal intensive care unit admissions.

The PreClara Ratio test must be calculated using specific B·R·A·H·M·S analyzers and is intended for use alongside other laboratory tests and clinical assessments. Trinity Biotech stated the launch prepares groundwork for the anticipated commercial introduction of PrePsia, the company's proprietary preeclampsia risk assessment technology for early pregnancy.

Trinity Biotech is a commercial-stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors.

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