Core Insights - Trinity Biotech has received regulatory approval from the New York State Department of Health for the PreClara™ Ratio (sFlt-1/PlGF) biomarker test, which is set to launch in Q3 2025, aimed at assessing preeclampsia risk in pregnant women [1][2] Company Developments - The approval is a significant milestone in Trinity Biotech's maternal health strategy, enhancing its position in the U.S. diagnostics market [2] - The PreClara™ test provides clinicians with actionable insights for managing patients with hypertensive disorders of pregnancy, potentially impacting around 500,000 women annually in the U.S. [2][4] - The test is expected to lead to neonatal cost savings exceeding $10 million per 1,000 patients by reducing preterm deliveries and NICU admissions [2] Industry Context - Preeclampsia affects approximately 5-8% of pregnancies and is a leading cause of maternal and neonatal complications, contributing to about 11% of maternal deaths and 15% of premature births in the U.S. [4] - The NYSDOH approval also sets the stage for the future introduction of PrePsia™, a proprietary technology for early pregnancy risk assessment related to preeclampsia [3]

Core Insights - Trinity Biotech has launched the FDA-cleared PreClara Ratio (sFlt-1/PlGF) biomarker test aimed at improving management of hypertensive disorders in pregnancy, with plans for rollout in Q3 2025 [1][2] - The test is expected to provide significant clinical and economic benefits, potentially saving over $10 million per 1,000 patients by reducing preterm deliveries and neonatal intensive care admissions [3] Company Developments - The launch of the sFlt-1/PlGF test is part of a strategic collaboration with Thermo Fisher Scientific, enhancing Trinity Biotech's capabilities in maternal health diagnostics [2] - CEO John Gillard emphasized that this launch marks a strategic milestone in the company's maternal health strategy and reflects its commitment to addressing urgent healthcare needs [3] Industry Context - Hypertensive disorders of pregnancy affect approximately 500,000 women annually in the U.S., making it a leading cause of maternal and neonatal complications [2] - Preeclampsia affects 5-8% of pregnancies and is responsible for about 11% of maternal deaths and 15% of premature births in the U.S., with cases nearly doubling since 2007 [5]