Core Insights - Trinity Biotech has received full regulatory approval for upstream manufacturing of its Uni-Gold™ HIV rapid test, marking a significant milestone in its transformation plan [1][2][5] Group 1: Regulatory Approvals - The recent approval from the in-country healthcare product regulatory authority is the final major regulatory milestone needed to implement the new offshore and outsourced manufacturing model for Uni-Gold™ HIV [2][5] - This approval follows the WHO authorization received in November 2025, which laid the groundwork for the current in-country manufacturing clearance [2][3] Group 2: Strategic Transition - The transition to an offshore and outsourced manufacturing model is expected to enhance cost efficiency and scalability for the production of Uni-Gold™ HIV [2][3][5] - This strategic move aims to expand gross margins, improve working capital efficiency, and support future demand growth for Uni-Gold™ HIV [6] Group 3: Company Overview - Trinity Biotech is a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors [8] - The company develops and markets diagnostic systems for point-of-care and clinical laboratory segments, with a recent expansion into the wearable biosensor industry through the acquisition of Waveform Technologies Inc. [8]