Trinity Biotech Receives Regulatory Approval to Begin FDA-Cleared PreClara™ Preeclampsia Testing Service

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]