The approval enables the company to transition upstream processes for its Uni-Gold HIV rapid test to an offshore manufacturing platform.
Trinity Biotech has received regulatory approval to begin upstream manufacturing activities for its Uni-Gold HIV rapid test under a new offshored and outsourced production model.
The Dublin-based biotechnology company announced Feb. 10 that it secured the final regulatory milestone needed to implement its new offshore manufacturing approach for the World Health Organization (WHO) prequalified diagnostic test.
The approval from an in-country healthcare product regulatory authority allows Trinity Biotech to transition some upstream processes to what the company describes as a more cost-efficient and scalable offshore manufacturing platform.
Trinity Biotech expects the strategic transition to expand gross margins, improve working capital, enhance scalability to support future demand growth, and strengthen the company’s long-term financial profile.
“This approval is a critical final milestone in the execution of our comprehensive transformation plan,” says John Gillard, Trinity Biotech president and chief executive officer, in a release. “Combined with our prior WHO authorization, Trinity now has the regulatory approvals to fully realize the potential of this outsourced and offshored manufacturing model for Uni-Gold HIV.”
Building on WHO Approval
The local regulatory approval builds on Trinity Biotech’s WHO approval for Uni-Gold HIV in November 2025, which authorized the company’s upstream manufacturing approach and served as the technical foundation for the final in-country manufacturing clearance.
Gillard says the new model will expand the company’s margin profile, enhance working capital efficiency, and provide the scalability required to serve the global HIV rapid testing market.
Trinity Biotech sells direct in the US and through a network of international distributors and partners in more than 75 countries.
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