Trinity Biotech Gets Approval for Outsourced Manufacturing of WHO-Prequalified HIV Test

Trinity Biotech has received approval to manufacture its WHO-prequalified TrinScreen HIV rapid test offshore and outsourced, enabling a more cost-effective and scalable production model. The company has begun manufacturing under this new model, marking a critical milestone in its transformation strategy. This approval is a key step in the company's efforts to transition upstream production from in-house operations.

Trinity Biotech has received key approval to commence offshore and outsourced manufacturing of its TrinScreen™ HIV rapid test. This strategic shift aims 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.ainvest.com/news/trinity-biotech-gains-approval-offshore-manufacturing-hiv-rapid-test-2508/
[2] https://www.biospace.com/press-releases/regulatory-approval-granted-for-commencement-of-trinity-biotechs-offshored-and-outsourced-manufacturing-of-its-flagship-rapid-hiv-test-facilitating-strategic-and-financial-performance-transformation
[3] https://www.quiverquant.com/news/Trinity+Biotech+Receives+Regulatory+Approval+for+Offshore+and+Outsourced+Manufacturing+of+TrinScreen%E2%84%A2+HIV+Rapid+Test