Trinity Biotech Granted Key Regulatory Approval for Offshore Manufacturing of TrinScreen™ HIV Rapid Test
Trinity Biotech plc, a commercial-stage biotechnology company specializing in human diagnostics and diabetes management solutions, announced on August 20, 2025, that it has received a crucial regulatory approval from the in-country healthcare product regulatory authority. This approval allows the company to initiate offshore and outsourced manufacturing of its flagship TrinScreen™ HIV rapid test, which is prequalified by the World Health Organization (WHO). The transition to this new manufacturing model is expected to expand gross margins, free up working capital, and reduce fixed costs, thereby supporting Trinity Biotech's broader profitability and growth objectives. This milestone marks a significant step in the company's transformation strategy and enhances its scalability while maintaining high product integrity and regulatory compliance.
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