2026-02-10, 11:30:51 a.m.
DUBLIN, Ireland — February 11, 2026 — Leads & Copy —
Trinity Biotech plc (Nasdaq: TRIB) has received full regulatory approval to begin upstream manufacturing activities for its Uni-Gold™ HIV rapid test under the company’s new offshored and outsourced production model.
The approval from the in‑country healthcare product regulatory authority marks the final regulatory milestone required to fully implement the new manufacturing model.
The company expects the strategic transition to expand gross margins, improve working capital, enhance scalability to support future Uni-Gold™ HIV demand growth, and strengthen the company’s long‑term financial profile.
John Gillard, Trinity Biotech President & Chief Executive Officer, said the approval is a critical final milestone in the execution of the company’s Comprehensive Transformation Plan. He added that the company now has the regulatory approvals to fully realize the potential of this outsourced and offshored manufacturing model for Uni-Gold™ HIV.
Trinity Biotech’s WHO approval for Uni-Gold™ HIV in November 2025 authorized the company’s upstream manufacturing approach and served as the technical foundation for the final in‑country manufacturing clearance.
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 for the point-of-care and clinical laboratory segments of the diagnostic market.
Trinity Biotech sells direct in the United States and through a network of international distributors and strategic partners in over 75 countries worldwide.
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.
The company 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.
