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
Uni-Gold and PreClara. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Uni-Gold FDA Regulatory Events
Uni-Gold is a drug developed by Trinity Biotech for the following indication: HIV Rapid Test.
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:
- Uni-Gold
- Announced Date:
- November 18, 2025
- Indication:
- HIV Rapid Test
Announcement
Trinity Biotech plc announced it has received World Health Organization (WHO) approval for the offshored and outsourced upstream manufacturing activities of its market leading Uni-Gold™ HIV rapid test, a well-established and cornerstone diagnostic product used in HIV screening programs internationally.
AI Summary
Trinity Biotech announced that the World Health Organization has approved the offshored and outsourced upstream manufacturing activities for its Uni-Gold™ HIV rapid test, a widely used diagnostic for HIV screening worldwide. The approval allows key early-stage production steps to be moved offshore while maintaining product integrity and regulatory compliance.
The change follows a roughly two-year project to shift upstream production from legacy in-house operations to third‑party, offshore manufacturers. Trinity plans to partner with experienced contract manufacturers and to implement the new model in the coming months, saying the transition preserves quality and meets WHO standards.
This approval is part of a broader transformation plan aimed at improving profitability. Trinity expects outsourcing to lower fixed costs and enhance gross margins, EBITDA and cash flow, while freeing internal resources to focus on innovation, market expansion and long‑term growth. Leadership calls the approval a key milestone for competitiveness.
Read Announcement
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
- Target Action Date:
- Q3 2025
- Estimated Target Date Range:
- July 1, 2025 - September 30, 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
Free TRIB Stock Alerts