Trinity Biotech plc announced on August 14, 2025, that its New York reference laboratory received regulatory approval from the New York State Department of Health (NYSDOH). This approval allows the company to begin providing the FDA-cleared PreClara™ Ratio (sFlt-1/PlGF) biomarker test for preeclampsia risk assessment. The service is planned to be rolled out in Q3 2025.
This approval marks a significant milestone in Trinity Biotech’s maternal health strategy and strengthens its position in the U.S. diagnostics market. The PreClara™ test provides clinicians with time-sensitive, clinically actionable insights to support informed decision-making for patients hospitalized with hypertensive disorders of pregnancy. Approximately 500,000 women in the United States are affected annually by these disorders.
Recent U.S.-based studies published in March 2025 demonstrated potential neonatal cost savings exceeding $10 million per 1,000 patients when the test is incorporated into standard care. This is primarily through reduced preterm deliveries and NICU admissions. The NYSDOH approval further lays critical groundwork for the anticipated commercial introduction of PrePsia™, Trinity Biotech’s proprietary preeclampsia risk assessment technology designed for use in early pregnancy.
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