Trinity Biotech Secures WHO Approval for Offshored Upstream Manufacturing of TrinScreen HIV

TRIB
October 04, 2025

Trinity Biotech plc announced on June 24, 2025, that it received World Health Organization (WHO) approval for the offshored and outsourced upstream manufacturing activities of its high-volume TrinScreen™ HIV rapid test. This regulatory approval marks a critical milestone in the company’s comprehensive transformation plan, which aims to restore financial performance and drive sustainable profitability. The approval enables Trinity Biotech to transition upstream production from its legacy in-house operations to a more cost-effective and scalable outsourced model.

This strategic manufacturing move is expected to deliver substantial improvements in gross margin and working capital. It will also enhance supply chain resilience and scalability for one of the company's principal diagnostic products. The transition to outsourced offshore upstream manufacturing is part of a broader initiative to streamline operations, reduce fixed costs, and reallocate internal resources towards innovation and market expansion.

CEO John Gillard stated that this approval is a major step forward in the company's transformation journey. By offshoring and outsourcing further upstream manufacturing activities, Trinity Biotech is unlocking significant cost efficiencies and improving operational agility. The company plans to implement this next phase of the new TrinScreen™ HIV manufacturing model in Q3 2025.

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