DUBLIN, Ireland — August 14, 2025 — Leads & Copy — Trinity Biotech plc (Nasdaq: TRIB) announced that its New York reference laboratory has received approval from the New York State Department of Health (NYSDOH) to provide the FDA-cleared PreClara™ Ratio (sFlt-1/PlGF) biomarker test for preeclampsia risk assessment. The service is planned for Q3 2025 rollout.
The approval strengthens Trinity Biotech’s position in the U.S. diagnostics market and marks a milestone in its maternal health strategy. The PreClara™ test supports informed decision-making for patients hospitalised with hypertensive disorders of pregnancy by providing clinicians with clinically actionable insights.
Approximately 500,000 women in the U.S. are affected annually by hypertensive pregnancy disorders, which are a leading cause of maternal and neonatal complications. Studies have demonstrated potential neonatal cost savings exceeding $10 million per 1,000 patients when the test is incorporated into standard care.
The NYSDOH approval lays groundwork for the anticipated commercial introduction of PrePsia™, Trinity Biotech’s proprietary preeclampsia risk assessment technology designed for early pregnancy use.
Preeclampsia is a hypertensive disorder affecting 5-8% of pregnancies, characterized by high blood pressure and organ dysfunction. Early diagnosis and intervention are crucial due to its contribution to maternal morbidity, mortality, and premature births. In the U.S., preeclampsia accounts for approximately 11% of maternal deaths and 15% of premature births.
The PreClara Ratio (sFlt-1/PlGF) is intended for use with other laboratory tests and clinical assessments to aid in the risk assessment of pregnant women (singleton pregnancies between 23+0 and 34+6/7 weeks gestation) hospitalized for hypertensive disorders of pregnancy.
Contact:
Trinity Biotech plc
Gary Keating, PhD
(353)-1-2769800
RedChip Companies Inc.
Dave Gentry, CEO
(1)-407-644-4256
(1)-800-RED-CHIP (733-2447)
TRIB@redchip.com
