Trinity Biotech plc has announced the launch of an FDA-cleared preeclampsia testing service, marking a significant advancement in maternal health diagnostics. The service, planned for rollout in the third quarter of 2025 through Trinity Biotech's New York-based reference laboratory, will offer the PreClara Ratio (sFlt-1/PlGF) biomarker test as part of a strategic collaboration with Thermo Fisher Scientific.
The testing service addresses a critical healthcare need, as approximately 500,000 women in the United States are impacted by hypertensive disorders of pregnancy each year, representing a leading cause of maternal and neonatal complications. Preeclampsia affects approximately 5-8% of pregnancies and is characterized by sudden onset high blood pressure and associated organ dysfunction signs such as protein in the urine or severe headache.
Clinical Application and Patient Population
The PreClara Ratio test is intended for use in conjunction with other laboratory tests and clinical assessments to aid in risk assessment of pregnant women with singleton pregnancies between 23+0 and 34+6/7 weeks gestation who are hospitalized for hypertensive disorders of pregnancy. The test helps assess the likelihood of progression to preeclampsia with severe features within two weeks of presentation, as defined by the American College of Obstetricians and Gynecologists.
The sFlt-1/PlGF test provides time-sensitive, clinically actionable insights that support healthcare providers in making earlier, more informed decisions for hospitalized patients. By enabling assessment of progression risk, the test facilitates more targeted and timely management of care for this high-risk patient population.
Economic Impact and Cost Savings
The clinical and economic value of the sFlt-1/PlGF test is supported by recent U.S.-based studies published in March 2025, which demonstrated potential neonatal cost savings exceeding $10 million per 1,000 patients when the test is incorporated into standard care. These substantial savings primarily stem from reduced preterm deliveries and neonatal intensive care unit admissions, highlighting both clinical efficacy and economic benefit.
The economic impact is particularly significant given that preeclampsia already accounts for approximately 11% of maternal deaths and 15% of premature births in the United States, with cases nearly doubling since 2007.
Strategic Implications
"This launch represents an important strategic milestone in Trinity Biotech's maternal health strategy, significantly enhancing our position in this critical clinical area, and is a further step in our transformation to focus on new technology platforms in large impact areas," said John Gillard, CEO of Trinity Biotech.
The launch of the sFlt-1/PlGF testing service establishes critical groundwork for the anticipated commercial introduction of PrePsia, Trinity Biotech's proprietary preeclampsia risk assessment technology designed for use in early pregnancy. This strategic development reflects the company's commitment to delivering value to shareholders through innovations that address urgent healthcare needs.
Technical Specifications
The PreClara Ratio must be calculated using the B·R·A·H·M·S sFlt-1 KRYPTOR and the B·R·A·H·M·S PlGF plus KRYPTOR results measured on the B·R·A·H·M·S KRYPTOR analyzer. The test is specifically designed for singleton pregnancies within the specified gestational age range and must be used as part of comprehensive clinical assessment protocols.
Trinity Biotech's expanding maternal health portfolio demonstrates the company's continued focus on supporting patients in critical healthcare areas while positioning itself strategically in the diagnostics market through technological innovation and strategic partnerships.
