Trinity Biotech has announced a significant step in its maternal health initiative, receiving regulatory approval from the New York State Department of Health (NYSDOH) to launch its FDA-cleared PreClara™ Ratio biomarker test. This approval allows the company to begin providing the new testing service in the third quarter of 2025. The PreClara™ test is designed to aid in the risk assessment of pregnant women hospitalized with hypertensive disorders of pregnancy, such as preeclampsia.
Preeclampsia is a serious and rapidly progressive hypertensive disorder that affects up to 8% of pregnancies and is a leading cause of maternal and neonatal complications. In the U.S., it accounts for 11% of maternal deaths and 15% of premature births, with the number of cases nearly doubling since 2007.
The PreClara™ Ratio test measures the ratio of two biomarkers, sFlt-1 and PlGF, to help clinicians determine the likelihood of a patient's condition progressing to severe preeclampsia within two weeks. This provides time-sensitive, clinically actionable information that can help doctors make more informed decisions about patient care, leading to better outcomes.
Studies have already shown the potential impact of this test. A recent U.S.-based study published in March 2025 demonstrated that incorporating the test into standard care could result in over $10 million in neonatal cost savings per 1,000 patients. These savings come primarily from reduced preterm deliveries and fewer admissions to the neonatal intensive care unit (NICU).
The NYSDOH approval not only marks a major milestone for Trinity Biotech's current services but also sets the stage for future innovations. It lays the groundwork for the anticipated commercial launch of PrePsia™, the company's proprietary technology designed for preeclampsia risk assessment in early pregnancy.