Trinity Biotech is an Irish medical diagnostics company that develops, manufactures, and sells diagnostic products for clinical laboratories and point-of-care settings, while also developing an early-stage continuous glucose monitoring (CGM) biosensor business. The core diagnostics business covers three main areas: HIV point-of-care testing, haemoglobin/diabetes instruments, and specialty diagnostic kits. In HIV, Trinity Biotech's Uni-Gold and TrinScreen tests serve the standard two-test HIV testing protocol used across Africa, sold primarily through NGO-funded and government programs tied to donor procurement cycles. In diabetes, the flagship Premier Hb9210 instrument measures HbA1c for diabetes monitoring, operating on a razor/razor blade model where instruments are placed with labs that then purchase recurring proprietary consumables. Trinity Biotech also sells a broad range of specialty kits covering autoimmune and infectious diseases. The Americas account for roughly 56% of revenues, with Trinity Biotech selling directly in the U.S., Brazil, and select European markets, and through distributors across roughly 100 countries elsewhere. On the growth side, Trinity Biotech is consolidating manufacturing and transitioning HIV test production to offshore contract manufacturers to improve margins. Longer-term, Trinity Biotech is building a biosensor platform anchored by its CGM+ device, acquired through the 2024 purchase of Waveform Technologies' assets, with pivotal clinical trials planned for 2026. Trinity Biotech also holds two early-stage diagnostic programs — PrePsia and EpiCapture — acquired in 2024.
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