Trinity Biotech receives approval for offshore manufacturing of HIV test

DUBLIN - Trinity Biotech plc (NASDAQ:TRIB), a micro-cap diagnostics company with a market value of $30 million, announced Wednesday that it has received regulatory approval to begin offshore and outsourced manufacturing of its TrinScreen HIV rapid test. According to InvestingPro data, the company’s stock has shown strong momentum with a 78% surge over the past six months.

The approval from an unnamed in-country healthcare product regulatory authority enables the company to transition production from its in-house operations to an outsourced model, according to a press release statement.

Trinity Biotech has already begun manufacturing under the new model, which the company expects will expand gross margins, free up working capital, and reduce fixed costs.

The latest approval follows a previous World Health Organization authorization for offshore and outsourced manufacturing activities of the HIV rapid test.

"This key regulatory approval is a major step forward in our transformation journey," said John Gillard, President and Chief Executive Officer of Trinity Biotech. "It allows us to fully operationalize our offshore manufacturing model for TrinScreen HIV."

Trinity Biotech, a commercial-stage biotechnology company, focuses on human diagnostics and diabetes management solutions, including wearable biosensors. The company develops, manufactures, and markets diagnostic systems for point-of-care and clinical laboratory segments.

The Dublin-based firm sells directly in the United States and through international distributors in over 75 countries worldwide.

In other recent news, Trinity Biotech has received regulatory approval from the New York State Department of Health for its FDA-cleared PreClara™ Ratio biomarker test, aimed at assessing the risk of preeclampsia. This service is expected to launch in the third quarter of 2025 through the company’s New York reference laboratory. The approval marks a significant milestone in Trinity Biotech’s maternal health strategy, enhancing its presence in the U.S. diagnostics market. Additionally, the company announced positive clinical trial results for its next-generation continuous glucose monitoring (CGM) technology. The redesigned, needle-free glucose sensor provides accurate readings over a 15-day period without requiring finger-stick calibration, representing a significant technical breakthrough. This advancement could potentially lower costs compared to current market products. The company has also launched its preeclampsia testing service, in collaboration with Thermo Fisher Scientific, set to roll out in 2025. These developments reflect Trinity Biotech’s ongoing efforts to innovate and expand its diagnostic offerings.

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