Trinity Biotech Secures Key Regulatory Approval for Offshored and Outsourced Manufacturing of Its Flagship Rapid HIV Test, Accelerating Strategic & Financial Performance Transformation

Original from: Trinity Biotech

Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced it has received World Health Organization (WHO) approval for the offshored and outsourced upstream manufacturing activities of its high-volume TrinScreen™ HIV rapid test, a cornerstone diagnostic product used in HIV screening programs. This regulatory approval marks a critical milestone in the Company’s comprehensive transformation plan aimed at restoring financial performance and driving sustainable profitability.

This key regulatory approval enables Trinity Biotech to transition upstream production from its legacy in-house operations to a more cost-effective and scalable outsourced model, while maintaining the highest levels of product integrity and regulatory compliance.

“This approval is a major step forward in our transformation journey,” said John Gillard, President & Chief Executive Officer of Trinity Biotech. “By offshoring and outsourcing the further upstream manufacturing activities of one of our principal products, we are unlocking significant cost efficiencies, improving operational agility & scalability, and positioning the Company for long-term financial health.”

The transition to outsourced offshore upstream manufacturing is expected to deliver substantial improvements in gross margin and working capital, while also enhancing supply chain resilience and scalability. The move is part of a broader strategic initiative to streamline operations, reduce fixed costs, and focus internal resources on innovation and market expansion.

Trinity Biotech will implement this next phase of this new TrinScreen™ HIV manufacturing model in Q3 2025.

Source: Trinity Biotech Secures Key Regulatory Approval for Offshored and Outsourced Manufacturing of Its Flagship Rapid HIV Test, Accelerating Strategic & Financial Performance Transformation