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DUBLIN - Trinity Biotech plc (NASDAQ:TRIB), a medical diagnostics company with a market capitalization of $18.76 million, has received regulatory approval from the New York State Department of Health to provide its FDA-cleared PreClara Ratio biomarker test for preeclampsia risk assessment, the company announced Thursday. The stock has shown strong momentum, gaining over 13% in the past week.
The test service is planned to launch in the third quarter of 2025 through Trinity’s New York reference laboratory. The PreClara Ratio test helps clinicians assess the likelihood that hospitalized pregnant women with hypertensive disorders will progress to severe preeclampsia within two weeks. According to InvestingPro analysis, Trinity Biotech maintains a ’FAIR’ financial health score despite operating with significant debt levels.
Preeclampsia, a rapidly progressive hypertensive disorder affecting approximately 5-8% of pregnancies, is characterized by sudden onset high blood pressure and signs of organ dysfunction. The condition contributes to approximately 11% of maternal deaths and 15% of premature births in the United States.
According to Trinity Biotech, hypertensive pregnancy disorders affect approximately 500,000 women annually in the United States. Recent U.S.-based studies published in March 2025 indicated potential neonatal cost savings exceeding $10 million per 1,000 patients when the test is incorporated into standard care, primarily through reduced preterm deliveries and NICU admissions.
The PreClara Ratio test is intended for use with pregnant women between 23 and 34 weeks gestation who are hospitalized for hypertensive disorders of pregnancy. The test must be calculated using specific KRYPTOR analyzer measurements.
The approval also supports groundwork for the anticipated commercial introduction of PrePsia, Trinity Biotech’s proprietary preeclampsia risk assessment technology designed for use in early pregnancy.
The information in this article is based on a company press release statement.
In other recent news, Trinity Biotech plc announced positive clinical trial results for its next-generation continuous glucose monitoring (CGM) technology. The redesigned needle-free glucose sensor delivered accurate glucose readings over a 15-day wear period without the need for finger-stick calibration. This development is a significant milestone in the company’s CGM+ platform, potentially reducing costs compared to existing market products. Additionally, Trinity Biotech has launched a preeclampsia testing service set to roll out in Q3 2025 through a collaboration with Thermo Fisher Scientific. The service will use the FDA-cleared PreClara Ratio biomarker test to help healthcare providers assess the risk of severe preeclampsia in pregnant women. In another development, the company received World Health Organization approval for offshored manufacturing of its TrinScreen HIV rapid test. This approval allows Trinity Biotech to transition to an outsourced production model while maintaining regulatory compliance. These developments highlight Trinity Biotech’s ongoing efforts in advancing healthcare technologies.
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