Trinity Biotech plc, a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors,did announced it has now received full regulatory approval for the commencement of upstream manufacturing activities for its flagship World Health Organisation (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.”