Trinity Biotech receives WHO approval for offshore HIV test manufacturing

Published 24/06/2025, 13:06
Trinity Biotech receives WHO approval for offshore HIV test manufacturing

DUBLIN - Trinity Biotech plc (NASDAQ:TRIB), currently trading at $0.55 per share with a market capitalization of approximately $10 million, has received World Health Organization approval for offshored and outsourced upstream manufacturing activities of its TrinScreen HIV rapid test, the company announced Tuesday.

The regulatory approval enables Trinity Biotech to transition production from in-house operations to an outsourced model while maintaining product integrity and regulatory compliance, according to the press release statement.

The biotechnology company, which focuses on human diagnostics and diabetes management solutions, plans to implement this new manufacturing model in the third quarter of 2025.

"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," said John Gillard, President and Chief Executive Officer of Trinity Biotech.

The company expects the manufacturing transition to deliver improvements in gross margin and working capital, while enhancing supply chain resilience and scalability. The move is part of a broader initiative to streamline operations, reduce fixed costs, and focus internal resources on innovation and market expansion. According to InvestingPro analysis, which offers 8 additional key insights about Trinity Biotech’s financial health, the company’s current gross profit margin stands at ~35%, highlighting the urgent need for operational improvements.

The TrinScreen HIV rapid test is used in HIV screening programs and represents a key product in Trinity Biotech’s diagnostic portfolio. The company develops, manufactures, and markets diagnostic systems for point-of-care and clinical laboratory segments, and has recently entered the wearable biosensor industry.

Trinity Biotech sells directly in the United States and through international distributors in over 75 countries worldwide. The stock, which has declined over 77% in the past year, currently appears undervalued according to InvestingPro’s Fair Value analysis. Discover comprehensive insights about Trinity Biotech and 1,400+ other stocks through InvestingPro’s detailed research reports, which transform complex financial data into actionable intelligence.

In other recent news, Trinity Biotech has announced a change in its executive leadership team. Susan O’Connor has been appointed as the Interim Chief Financial Officer, effective April 11, 2025, taking over from Louise Tallon. O’Connor brings extensive experience to the role, having worked with multiple public companies in sectors such as Technology, Health, and Life Sciences. The company confirmed that Tallon’s departure was not due to any internal disagreements concerning operations, policies, or practices. Trinity Biotech expressed gratitude for Tallon’s contributions and wished her success in her future endeavors. The company also reiterated its forward-looking statements about its financial position, growth potential, and operational goals. These statements, however, are subject to risks and uncertainties as detailed in their annual report and other SEC filings.

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