Trinity Biotech plc 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.
The commercial-stage biotechnology company, which focuses on human diagnostics and diabetes management solutions including wearable biosensors, can now 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.
Strategic Manufacturing Transformation
"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 represents part of a broader strategic initiative to streamline operations, reduce fixed costs, and focus internal resources on innovation and market expansion.
Implementation Timeline and Expected Benefits
Trinity Biotech will implement this next phase of the new TrinScreen™ HIV manufacturing model in Q3 2025. The strategic offshore manufacturing move is expected to drive gross margin expansion, free up working capital, and enhance scalability while reducing fixed costs to support the company's broader profitability and growth objectives.
The WHO approval specifically covers the offshored and outsourced upstream manufacturing activities of TrinScreen HIV, supporting Trinity Biotech's transformation plan focused on financial turnaround and sustainable growth. The company expects the changes to improve gross margins, reduce fixed costs, and enhance supply chain agility.
Trinity Biotech develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market. The company has recently entered the wearable biosensor industry with the acquisition of biosensor assets from Waveform Technologies Inc., intending to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring product.
