Trinity Biotech Secures Regulatory Approval for Commencement of Upstream Manufacturing Activities of Uni-Gold™ HIV Rapid Test Under Its Offshored and Outsourced Model, Supporting Financial Performance Transformation
Rhea-AI Summary
Trinity Biotech (Nasdaq: TRIB) received final local regulatory approval to begin upstream manufacturing of its WHO‑prequalified Uni‑Gold™ HIV rapid test under an offshored and outsourced production model. This clearance completes the regulatory milestones needed to implement the new manufacturing approach.
The company says the transition to offshore upstream processes is expected to expand gross margins, improve working capital efficiency, and enhance scalability, supporting its Comprehensive Transformation Plan and long‑term financial profile. The approval follows WHO authorisation in November 2025.
Positive
- Final local regulatory approval enables offshore upstream manufacturing for Uni‑Gold HIV
- WHO prequalification in November 2025 provided the technical foundation for local clearance
- Company expects the new model to expand gross margins and improve working capital efficiency
- Offshored and outsourced approach is designed to increase manufacturing scalability for future demand
Negative
- None.
Market Reaction
Following this news, TRIB has declined 4.93%, reflecting a moderate negative market reaction. Our momentum scanner has triggered 13 alerts so far, indicating notable trading interest and price volatility. The stock is currently trading at $0.83. This price movement has removed approximately $844K from the company's valuation. Trading volume is very high at 3.3x the average, suggesting heavy selling pressure.
Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.
Market Reality Check
Peers on Argus
Momentum scanner shows only one peer (VVOS) moving up, and broader Medical Devices peers show mixed moves from -7.03% (ADGM) to +113.16% (PTHL), indicating this catalyst is stock-specific rather than a sector-wide move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 23 | Capital structure update | Positive | +43.5% | New Perceptive credit agreements to bolster liquidity and extend debt maturity. |
| Dec 23 | Major order & results | Positive | +43.5% | 9M-unit TrinScreen HIV order and stronger Q3 revenue, margin and EBITDA. |
| Dec 15 | Product rollout expansion | Positive | -12.2% | Global rollout of high-capacity HbA1c system after new regulatory clearances. |
| Nov 18 | WHO manufacturing approval | Positive | +0.5% | WHO approval for offshored Uni-Gold HIV upstream manufacturing to boost efficiency. |
| Nov 14 | Clinical collaboration | Positive | +3.1% | Collaboration to enhance epigenetic analysis for late-stage EpiCapture test. |
Positive operational and regulatory updates have often coincided with favorable price reactions, with only one notable divergence on a product rollout announcement.
Over the past few months, Trinity Biotech reported several milestones tied to its Comprehensive Transformation Plan. On Nov 18, 2025, WHO approval for offshored Uni-Gold HIV manufacturing targeted improved gross margins, EBITDA and cashflow. A major TrinScreen HIV order and stronger Q3 2025 metrics were followed by agreements with Perceptive Advisors to strengthen liquidity and extend credit maturity to Jan 15, 2027. The current in‑country approval for Uni-Gold upstream manufacturing directly builds on the prior WHO authorization and advances the same transformation strategy.
Market Pulse Summary
This announcement finalizes in‑country regulatory clearance for upstream Uni-Gold HIV manufacturing under Trinity Biotech’s offshored and outsourced model, building on prior WHO approval from November 2025. It ties directly into the company’s Comprehensive Transformation Plan, which has emphasized margin expansion, working capital efficiency, and scalability. In assessing impact, investors may watch future disclosures on gross margin trends, cashflow, and how quickly the new manufacturing structure ramps in tandem with Uni-Gold demand.
Key Terms
World Health Organization (WHO) regulatory
biosensors medical
AI-generated analysis. Not financial advice.
- Approval Marks Final Regulatory Milestone Required to Enable Launch of Upstream Manufacturing Activities Under New Offshored & Outsourced Production Model
- Expected to Drive Gross Margin Expansion, Improve Working Capital Efficiency, and Enhance Long‑Term Scalability
- Represents a Key Final Component of the Company’s Comprehensive Transformation Plan
DUBLIN, Ireland, Feb. 10, 2026 (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 it has now received full regulatory approval for the commencement of upstream manufacturing activities for its flagship World Health Organization (WHO) prequalified Uni-Gold™ HIV rapid test under the Company’s offshored and outsourced production model.
This latest approval from the in‑country healthcare product regulatory authority marks the final major regulatory milestone required to fully implement Trinity Biotech’s new offshore & outsourced manufacturing model for Uni-Gold™ HIV, enabling the Company to transition some upstream processes to a more cost‑efficient and highly scalable offshore manufacturing platform.
The strategic transition is expected to:
- Expand gross margins;
- Improve working capital;
- Enhance scalability to support future Uni-Gold™ HIV demand growth;
- Strengthen the Company’s long‑term financial profile as part of its Comprehensive Transformation Plan.
This local regulatory approval builds on Trinity Biotech’s WHO approval for Uni-Gold™ HIV in November 2025, which authorised the Company’s upstream manufacturing approach and served as the technical foundation for this final in‑country manufacturing clearance.
John Gillard, Trinity Biotech President & Chief Executive Officer, commented:
“This approval is a critical final milestone in the execution of our Comprehensive Transformation Plan. Combined with our prior WHO authorisation, Trinity now has the regulatory approvals to fully realise the potential of this outsourced and offshored manufacturing model for Uni-Gold™ HIV. This model will expand our margin profile, enhance our working capital efficiency, and provide the scalability required to serve the global HIV rapid testing market for years to come.”
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, our ability to reduce our debt and improve our capitalization, 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. |
| Paul Murphy | Dave Gentry, CEO | |
| (353)-1-2769800 | (1)-407-644-4256 | |
| (1)-800-RED-CHIP (733-2447) | ||
| TRIB@redchip.com |
FAQ
What regulatory approval did Trinity Biotech (TRIB) announce on February 10, 2026?
How will the Uni‑Gold™ HIV manufacturing change affect TRIB's margins and capital?
Does the February 2026 approval mean Trinity can fully implement outsourced production for Uni‑Gold™ HIV?
What role did WHO authorisation play in Trinity Biotech's manufacturing approval for Uni‑Gold™ HIV?
What operational benefits does Trinity Biotech (TRIB) cite from the new Uni‑Gold™ HIV production model?
How does the new manufacturing model affect Uni‑Gold™ HIV's ability to meet global demand for rapid tests?
