Trinity Biotech Gains Approval for Offshore Manufacturing of HIV Rapid Test.

Trinity Biotech has received key approval for offshore and outsourced manufacturing of its TrinScreen HIV rapid test. The transition will drive gross margin expansion, free up working capital, and enhance scalability. Outsourced production reduces fixed costs, supporting Trinity's broader profitability and growth objectives.

Trinity Biotech (Nasdaq: TRIB) has received key approval to commence offshore and outsourced manufacturing of its flagship TrinScreen™ HIV rapid test. This strategic shift is set to drive gross margin expansion, free up working capital, and enhance scalability, while also reducing fixed costs and supporting the company's broader profitability and growth objectives.

The approval, granted by the in-country healthcare product regulatory authority, allows Trinity Biotech to transition upstream production from its legacy in-house operations to a more cost-effective and scalable outsourced model. The company has already initiated manufacturing under this new framework, marking a critical milestone in its transformation strategy.

The TrinScreen™ HIV rapid test, which carries World Health Organization (WHO) prequalification status, is crucial for HIV testing in developing markets. The transition to outsourced manufacturing addresses three key financial challenges simultaneously: it should expand gross margins by lowering production costs, free up working capital previously tied to inventory and raw materials, and reduce fixed costs by eliminating the overhead associated with maintaining in-house production facilities.

"This key regulatory approval is a major step forward in our transformation journey," said John Gillard, President and Chief Executive Officer of Trinity Biotech. "It builds on our earlier WHO authorization and allows us to fully operationalize our offshore manufacturing model for TrinScreen™ HIV. This transition unlocks significant cost efficiencies, enhances scalability, and positions the Company for long-term financial health."

The dual approvals from both the local regulatory authority and the WHO indicate that Trinity Biotech has successfully navigated the complex regulatory requirements for this transition while preserving product integrity.

References:
[1] https://www.stocktitan.net/news/TRIB/regulatory-approval-granted-for-commencement-of-trinity-biotech-s-6fkk9zyvc2p8.html
[2] https://www.globenewswire.com/news-release/2025/08/20/3136468/8624/en/Regulatory-Approval-Granted-for-Commencement-of-Trinity-Biotech-s-Offshored-and-Outsourced-Manufacturing-of-its-Flagship-Rapid-HIV-Test-Facilitating-Strategic-and-Financial-Perform.html