Trinity Biotech's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Trinity Biotech (TRIB).
Over the past two years, Trinity Biotech has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
PreClara. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
PreClara FDA Regulatory Events
PreClara is a drug developed by Trinity Biotech for the following indication: Preeclampsia Testing Service.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PreClara
- Announced Date:
- August 14, 2025
- Estimated Event Date Range:
- July 1, 2025 - September 30, 2025
- Target Action Date:
- Q3 2025
- Indication:
- Preeclampsia Testing Service
Announcement
Trinity Biotech plc announced that this week its New York, reference laboratory has received regulatory approval from the New York State Department of Health (NYSDOH) 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.
AI Summary
Trinity Biotech plc announced that its New York reference laboratory has received approval from the New York State Department of Health to offer the FDA-cleared PreClara™ Ratio (sFlt-1/PlGF) biomarker test for assessing the risk of preeclampsia. The service is set to launch in the third quarter of 2025. This approval supports Trinity Biotech’s maternal health strategy and strengthens its position in the U.S. diagnostics market.
The PreClara™ Ratio test gives clinicians time-sensitive, actionable insights to guide care for hospitalized pregnant women with hypertensive disorders. In the United States, about 500,000 women annually face these conditions, which can lead to serious complications. Recent studies indicate that using the PreClara™ test could save more than $10 million in neonatal costs per 1,000 patients by reducing preterm deliveries and NICU stays.
This NYSDOH approval also paves the way for Trinity Biotech’s next innovation, PrePsia™, a proprietary technology for early-pregnancy preeclampsia risk assessment.
Read Announcement
Trinity Biotech FDA Events - Frequently Asked Questions
As of now, Trinity Biotech (TRIB) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Trinity Biotech (TRIB) has reported FDA regulatory activity for PreClara.
The most recent FDA-related event for Trinity Biotech occurred on August 14, 2025, involving PreClara. The update was categorized as "Regulatory Update," with the company reporting: "Trinity Biotech plc announced that this week its New York, reference laboratory has received regulatory approval from the New York State Department of Health (NYSDOH) 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."
Currently, Trinity Biotech has one therapy (PreClara) targeting the following condition: Preeclampsia Testing Service.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:TRIB) was last updated on 8/15/2025 by MarketBeat.com Staff
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