PrePsia™

Search documents
Trinity Biotech Receives Regulatory Approval to Begin FDA-Cleared PreClara™ Preeclampsia Testing Service
Globenewswire· 2025-08-14 13:00
About Preeclampsia Preeclampsia is a rapidly progressive hypertensive disorder affecting approximately 5-8% of pregnancies, characterized by sudden onset high blood pressure and an associated sign of organ dysfunction like protein in the urine or severe headache. Early diagnosis and intervention are crucial, as preeclampsia significantly contributes to maternal morbidity, mortality, and premature births. In the United States, the condition already accounts for approximately 11% of maternal deaths and 15% of ...
Trinity Biotech Announces Launch of FDA-cleared Preeclampsia Testing Service
Globenewswire· 2025-08-07 12:00
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]