Trinity Biotech Announces Launch of FDA-cleared Preeclampsia Testing Service
Trinity Biotech (NASDAQ:TRIB) has announced the launch of its FDA-cleared PreClara™ Ratio (sFlt-1/PlGF) biomarker test for preeclampsia detection through its New York-based reference laboratory in Q3 2025. The test, developed in collaboration with Thermo Fisher Scientific, aims to address hypertensive disorders affecting approximately 500,000 women annually in the United States.
The test enables healthcare providers to make earlier, informed decisions for hospitalized patients by assessing the likelihood of progression to severe preeclampsia. Recent U.S. studies indicate potential neonatal cost savings exceeding $10 million per 1,000 patients when integrated into standard care, primarily through reduced preterm deliveries and NICU admissions.
This launch precedes the planned introduction of PrePsia™, Trinity Biotech's proprietary preeclampsia risk assessment technology for early pregnancy.
Trinity Biotech (NASDAQ:TRIB) ha annunciato il lancio del suo test biomarcatore PreClara™ Ratio (sFlt-1/PlGF), approvato dalla FDA, per la rilevazione della preeclampsia tramite il suo laboratorio di riferimento con sede a New York, previsto per il terzo trimestre del 2025. Il test, sviluppato in collaborazione con Thermo Fisher Scientific, è destinato a contrastare i disturbi ipertensivi che colpiscono circa 500.000 donne ogni anno negli Stati Uniti.
Il test consente ai professionisti sanitari di prendere decisioni tempestive e informate per i pazienti ospedalizzati, valutando la probabilità di evoluzione verso una forma grave di preeclampsia. Studi recenti negli Stati Uniti evidenziano potenziali risparmi sui costi neonatali superiori a 10 milioni di dollari ogni 1.000 pazienti se integrato nella pratica clinica standard, soprattutto grazie alla riduzione dei parti pretermine e delle ammissioni in terapia intensiva neonatale.
Questo lancio anticipa l’introduzione prevista di PrePsia™, la tecnologia proprietaria di Trinity Biotech per la valutazione del rischio di preeclampsia nelle prime fasi della gravidanza.
Trinity Biotech (NASDAQ:TRIB) ha anunciado el lanzamiento de su prueba biomarcadora PreClara™ Ratio (sFlt-1/PlGF), aprobada por la FDA, para la detección de la preeclampsia a través de su laboratorio de referencia en Nueva York, previsto para el tercer trimestre de 2025. La prueba, desarrollada en colaboración con Thermo Fisher Scientific, está dirigida a abordar los trastornos hipertensivos que afectan aproximadamente a 500,000 mujeres anualmente en Estados Unidos.
La prueba permite a los profesionales de la salud tomar decisiones más tempranas e informadas para pacientes hospitalizados, evaluando la probabilidad de progresión a preeclampsia grave. Estudios recientes en EE. UU. indican un potencial ahorro en costos neonatales que supera los 10 millones de dólares por cada 1,000 pacientes cuando se integra en la atención estándar, principalmente por la reducción de partos prematuros y admisiones en la unidad de cuidados intensivos neonatales.
Este lanzamiento precede la introducción planificada de PrePsia™, la tecnología propia de Trinity Biotech para la evaluación del riesgo de preeclampsia en el embarazo temprano.
Trinity Biotech (NASDAQ:TRIB)는 2025년 3분기에 뉴욕에 위치한 참조 연구소를 통해 FDA 승인을 받은 PreClara™ Ratio (sFlt-1/PlGF) 바이오마커 검사를 출시한다고 발표했습니다. 이 검사는 Thermo Fisher Scientific과 협력하여 개발되었으며, 미국에서 매년 약 50만 명의 여성에게 영향을 미치는 고혈압성 질환 문제를 해결하는 것을 목표로 합니다.
이 검사는 입원 환자의 중증 전자간증 진행 가능성을 평가하여 의료진이 더 빠르고 정확한 결정을 내릴 수 있도록 돕습니다. 최근 미국 연구에 따르면 표준 치료에 통합할 경우 1,000명당 1,000만 달러 이상의 신생아 비용 절감 효과가 있으며, 이는 주로 조산 및 신생아 집중 치료실(NICU) 입원 감소에 기인합니다.
이번 출시는 임신 초기 전자간증 위험 평가를 위한 Trinity Biotech의 독자 기술인 PrePsia™ 출시를 앞두고 있습니다.
Trinity Biotech (NASDAQ:TRIB) a annoncé le lancement de son test biomarqueur PreClara™ Ratio (sFlt-1/PlGF), approuvé par la FDA, pour la détection de la prééclampsie via son laboratoire de référence basé à New York, prévu pour le troisième trimestre 2025. Ce test, développé en collaboration avec Thermo Fisher Scientific, vise à traiter les troubles hypertensifs affectant environ 500 000 femmes chaque année aux États-Unis.
Le test permet aux professionnels de santé de prendre des décisions plus précoces et éclairées pour les patientes hospitalisées en évaluant la probabilité d'évolution vers une prééclampsie sévère. Des études récentes aux États-Unis indiquent des économies potentielles sur les coûts néonatals dépassant 10 millions de dollars pour 1 000 patientes lorsqu'il est intégré aux soins standards, principalement grâce à la réduction des naissances prématurées et des admissions en unité de soins intensifs néonatals.
Ce lancement précède l’introduction prévue de PrePsia™, la technologie propriétaire de Trinity Biotech pour l’évaluation du risque de prééclampsie en début de grossesse.
Trinity Biotech (NASDAQ:TRIB) hat die Einführung seines von der FDA zugelassenen PreClara™ Ratio (sFlt-1/PlGF) Biomarkertests zur Präeklampsie-Erkennung über sein Referenzlabor in New York für das dritte Quartal 2025 angekündigt. Der Test, entwickelt in Zusammenarbeit mit Thermo Fisher Scientific, soll hypertensive Erkrankungen adressieren, die jährlich etwa 500.000 Frauen in den USA betreffen.
Der Test ermöglicht es medizinischem Fachpersonal, frühere und fundierte Entscheidungen für hospitalisierte Patientinnen zu treffen, indem er die Wahrscheinlichkeit einer Verschlechterung zu schwerer Präeklampsie bewertet. Aktuelle US-Studien zeigen potenzielle Neonatalkosteneinsparungen von über 10 Millionen US-Dollar pro 1.000 Patienten, wenn der Test in die Standardversorgung integriert wird, vor allem durch reduzierte Frühgeburten und weniger Aufnahmen auf der Neugeborenen-Intensivstation.
Dieser Launch erfolgt vor der geplanten Einführung von PrePsia™, Trinity Biotechs eigener Technologie zur Risikobewertung von Präeklampsie in der Frühschwangerschaft.
- FDA clearance obtained for PreClara Ratio biomarker test
- Strategic collaboration established with Thermo Fisher Scientific
- Potential cost savings of over $10M per 1,000 patients demonstrated in studies
- Large addressable market of 500,000 women annually in the US
- Positions company for future launch of proprietary PrePsia technology
- Service rollout limited initially to New York-based reference laboratory
- Test currently restricted to hospitalized patients only
Insights
Trinity Biotech's FDA-cleared preeclampsia test represents a strategic entry into high-value maternal diagnostics with significant market and revenue potential.
Trinity Biotech's launch of the FDA-cleared PreClara™ Ratio (sFlt-1/PlGF) biomarker test represents a significant strategic expansion into the maternal health diagnostics market. This test addresses a critical clinical need affecting approximately 500,000 women annually in the United States who suffer from hypertensive disorders of pregnancy.
The test provides actionable clinical insights that help healthcare providers assess the likelihood of progression to severe preeclampsia, enabling more targeted patient management. From a market perspective, this positions Trinity Biotech in a high-value diagnostic segment with substantial growth potential.
The economic value proposition is particularly compelling. Recent U.S. studies indicate potential cost savings exceeding
Strategically, this launch serves as foundation for Trinity's broader maternal health portfolio, including their proprietary PrePsia™ technology for early pregnancy risk assessment. The collaboration with Thermo Fisher Scientific adds further credibility and leverages established distribution networks.
The Q3 2025 rollout through Trinity's New York reference laboratory suggests near-term revenue potential, providing a new growth driver beyond their existing diabetes management solutions. This diversification strengthens the company's market position while addressing an underserved clinical need with significant societal impact.
FDA-cleared PreClara™ Ratio (sFlt-1/PlGF) biomarker test offers clinicians a crucial tool for managing hypertensive disorders of pregnancy, with potential significant cost savings and improved patient outcomes
DUBLIN, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced the launch of a new testing service for preeclampsia, a significant advancement in maternal health diagnostics. The service is planned to be rolled out in Q3 2025 through Trinity Biotech’s New York-based reference laboratory.
Trinity Biotech will offer the FDA-cleared PreClara Ratio (sFlt-1/PlGF) biomarker test as part of a strategic collaboration with Thermo Fisher Scientific, enhancing Trinity Biotech's capabilities to deliver critical maternal health diagnostics. Approximately 500,000 women in the United States every year are impacted by hypertensive disorders of pregnancy - a leading cause of maternal and neonatal complications. The sFlt-1/PlGF test provides time-sensitive, clinically actionable insights that support healthcare providers in making earlier, more informed decisions for hospitalized patients. By helping to assess the likelihood of progression to severe preeclampsia, the test enables more targeted and timely management of care for this high-risk patient population.
“This launch represents an important strategic milestone in Trinity Biotech’s maternal health strategy, significantly enhancing our position in this critical clinical area, and is a further step in our transformation to focus on new technology platforms in large impact areas,” said John Gillard, CEO of Trinity Biotech. “Our expanding maternal health portfolio reflects our continued commitment to delivering value for our shareholders through innovations that address urgent healthcare needs, and as a company we are very proud to be part of supporting patients in this important healthcare area.”
The clinical and economic value of the sFlt-1/PlGF test is reinforced by recent U.S.-based studies. Research published in March 2025 demonstrated potential neonatal cost savings exceeding
The launch of the sFlt-1/PlGF testing service lays critical groundwork for the anticipated commercial introduction of PrePsia™, Trinity Biotech’s proprietary preeclampsia risk assessment technology designed for use in early pregnancy.
About Preeclampsia
Preeclampsia is a rapidly progressive hypertensive disorder affecting approximately 5
PreClara Ratio (sFlt-1/PlGF) Intended Use
The PreClara Ratio (sFlt-1/PlGF) is to be used in conjunction 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 (preeclampsia, chronic hypertension with or without superimposed preeclampsia, or gestational hypertension) for progression to preeclampsia with severe features (as defined by American College of Obstetricians and Gynecologists) within two weeks of presentation. The PreClara Ratio must be calculated using the B·R·A·H·M·S sFlt-1 KRYPTOR and the B·R·A·H·M·S PlGF plus KRYPTOR results measured on the B·R·A·H·M·S KRYPTOR analyzer.
1 https://doi.org/10.1016/j.preghy.2025.101190
2 https://www.preeclampsia.org/women-and-families
3 https://doi.org/10.1097/aog.0000000000004361
4 https://my.clevelandclinic.org/health/diseases/17952-preeclampsia
5 https://doi.org/10.1001/jamanetworkopen.2022.28093
Forward-Looking Statements
This release includes statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Reform Act”), including but not limited to statements related to Trinity Biotech’s cash position, financial resources and potential for future growth, market acceptance and penetration of new or planned product offerings, and future recurring revenues and results of operations. Trinity Biotech claims the protection of the safe harbor for forward-looking statements contained in the Reform Act. These forward-looking statements are often characterized by the terms “may,” “believes,” “projects,” “expects,” “anticipates,” or words of similar import, and do not reflect historical facts. Specific forward-looking statements contained in this release may be affected by risks and uncertainties, including, but not limited to, our ability to capitalize on the Waveform transaction and of our recent acquisitions, our continued listing on the Nasdaq Stock Market, our ability to achieve profitable operations in the future, the impact of the spread of COVID-19 and its variants, the possible pause and/or disruption in U.S. Government funding for HIV tests produced by Trinity Biotech, potential excess inventory levels and inventory imbalances at the company’s distributors, losses or system failures with respect to Trinity Biotech’s facilities or manufacturing operations, the effect of exchange rate fluctuations on international operations, fluctuations in quarterly operating results, dependence on suppliers, the market acceptance of Trinity Biotech’s products and services, the continuing development of its products, required government approvals, risks associated with manufacturing and distributing its products on a commercial scale free of defects, risks related to the introduction of new instruments manufactured by third parties, risks associated with competing in the human diagnostic market, risks related to the protection of Trinity Biotech’s intellectual property or claims of infringement of intellectual property asserted by third parties and risks related to condition of the United States economy and other risks detailed under “Risk Factors” in Trinity Biotech’s annual report on Form 20-F for the fiscal year ended December 31, 2024 and Trinity Biotech’s other periodic reports filed from time to time with the United States Securities and Exchange Commission. Forward-looking statements speak only as of the date the statements were made. Trinity Biotech does not undertake and specifically disclaims any obligation to update any forward-looking statements.
About Trinity Biotech
Trinity Biotech is a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors. The Company develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market and has recently entered the wearable biosensor industry, with the acquisition of the biosensor assets of Waveform Technologies Inc. and intends to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring product. Our products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information, please see the Company's website: www.trinitybiotech.com.
| Contact: | Trinity Biotech plc | RedChip Companies Inc. |
| Gary Keating, PhD | Dave Gentry, CEO | |
| (353)-1-2769800 | (1)-407-644-4256 | |
| (1)-800-RED-CHIP (733-2447) | ||
| TRIB@redchip.com |
FAQ
When will Trinity Biotech (TRIB) launch its PreClara preeclampsia testing service?
What are the cost savings associated with Trinity Biotech's PreClara test?
How many patients could benefit from Trinity Biotech's preeclampsia test?
What is the partnership between Trinity Biotech and Thermo Fisher Scientific?
What is Trinity Biotech's future plan for preeclampsia testing?
