Trinity Biotech

What Trinity Biotech does

Trinity Biotech plc is a commercial-stage diagnostics company founded in 1992 and headquartered in Bray, Ireland, listed on NASDAQ under ticker TRIB. The company develops, manufactures, and markets diagnostic systems, reagents, and instrumentation for point-of-care and clinical laboratories, with products spanning infectious disease testing (including WHO-prequalified Uni-Gold and TrinScreen HIV rapid tests), HbA1c diabetes monitoring (Premier Hb9210 with patented boronate affinity HPLC technology), hemoglobin variant detection (Premier Resolution), autoimmune diagnostics (ImmuGlo IFA, ImmuLisa ELISA, Captia infectious disease ELISA), and reference laboratory services through its Immco Diagnostics subsidiary. The company serves clinical laboratories, hospitals, blood banks, point-of-care facilities, and global health organizations across more than 100 countries through direct US sales and an international distributor network.

The company's revenue model combines one-time instrument sales (HPLC analyzers) with recurring consumables revenue (buffer reagents, calibrators, controls, analytical columns), plus large-volume government and global health procurement contracts for HIV rapid tests. Recent strategic acquisitions have expanded the pipeline into next-generation diagnostics: Metabolomic Diagnostics (2024) added the PrePsia preeclampsia risk assessment test using metabolomics and proprietary ML algorithms; WaveForm Technologies biosensor assets (2024) seeded the AI-native CGM+ continuous glucose monitoring platform unveiled in July 2025, which combines glucose sensing with heart activity, body temperature, and physical activity tracking for real-time AI analytics. The EpiCapture prostate cancer test, developed in-house and validated at 85% clinical accuracy in March 2026, extends the company into epigenetic liquid biopsy.

Most recently, Trinity Biotech launched the Trinovium subsidiary in June 2026 to apply its manufacturing and biosensing capabilities to dielectric fluid and fluid intelligence systems for liquid-cooled AI data centers, representing a strategic pivot into AI infrastructure. Trailing 12-month revenue stood at $48.6M as of September 30, 2025, with Q1 2026 revenue of $10.8M representing 43% year-on-year growth and gross margin expanding from 25.2% to 35.4% under a Comprehensive Transformation Plan. The company faces near-term capital structure challenges with February 2026 Nasdaq non-compliance notices for minimum bid price ($1.00) and minimum market value ($15M), and small market capitalization of approximately $13.91M.

Name

Trinity Biotech

Legal name

Trinity Biotech plc

Website

http://trinitybiotech.com

Company type

Public

Founded year

1992

Operating status

Operating

Headcount range

251–500 employees

Short description

Trinity Biotech plc is a commercial-stage diagnostics company developing and selling clinical laboratory and point-of-care tests for HIV, diabetes, hemoglobinopathies, autoimmune disorders, and infectious diseases across 100+ countries, with a growing pipeline in AI-driven wearable biosensors and epigenetic cancer diagnostics.

Ownership category

akta.pro rank

Product category

Clinical Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516), Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826), Services-Medical Laboratories (8071)

akta.pro primary industry

Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI)

akta.pro secondary industries

Molecular Diagnostics & Genomics Laboratories (HLAFAMAE), Biosensors & Lab-on-Chip (BioMEMS) (HDAHALAK)

Keywords

• Clinical diagnostics
• HIV rapid tests
• HbA1c analyzers
• Autoimmune diagnostics
• Continuous glucose monitoring

Headquarters

HQ city

Bray

HQ country

Ireland

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Operations, Technology or R&D, Personnel, Marketing or Sales, Infrastructure

Revenue model

1. Diagnostic Products and Reagents: Trinity Biotech generates revenue through the sale of diagnostic systems including reagents and instrumentation for point-of-care and clinical laboratory markets. Products include HbA1c analyzers, HIV rapid tests, autoimmune assays, infectious disease tests, and hemoglobinopathy detection systems. Consumable reagents and columns represent recurring revenue streams.
2. Instrument Systems: Sale of laboratory instrumentation including Premier Hb9210 and Premier Resolution HPLC analyzers. Instruments provide platform stickiness and drive ongoing consumable revenue.
3. Recurring Consumables and Reagents: Recurring revenue from consumables including buffer reagents, calibrators, controls, and analytical columns for installed instrument base. The company reported gross margin improvement from 25.2% to 35.4% under its Comprehensive Transformation Plan.

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

Trinity Biotech develops, manufactures, and markets diagnostic systems, including reagents and instrumentation, for point-of-care and clinical laboratories. Its product portfolio detects infectious diseases (notably HIV), sexually transmitted diseases, autoimmune disorders, and hemoglobin disorders, and monitors diabetic markers through HbA1c testing. The company has recently entered the wearable biosensor industry with an AI-native continuous glucose monitoring (CGM+) platform.

Product overview

Trinity Biotech is a commercial-stage diagnostics company with a diversified product portfolio spanning point-of-care and clinical laboratory segments. The core product portfolio includes the FDA 510(k) cleared Premier Hb9210 HbA1c analyser (boronate affinity HPLC for diabetes monitoring) and Premier Resolution system (ion-exchange HPLC for haemoglobin variant detection), both leaders in haemoglobin analysis. The infectious disease portfolio features WHO-prequalified rapid HIV tests (Uni-Gold and TrinScreen) used in national testing algorithms globally, plus comprehensive ELISA and IFA test menus for infectious diseases (HSV, CMV, EBV, Syphilis, Malaria, etc.) and autoimmune disorders (ImmuGlo, ImmuLisa brands). Innovation pipeline includes the AI-native CGM+ wearable biosensor platform (continuous glucose monitoring with multi-sensor health tracking), EpiCapture prostate cancer liquid biopsy test (epigenetic/machine learning-based risk prediction), and PrePsia preeclampsia risk assessment (metabolomics + machine learning). The company also operates Immco Diagnostics reference laboratory and has launched Trinovium for AI data center cooling solutions.

Differentiator

Problem solved

Functional benefit

Brands

• Uni-Gold: WHO-prequalified HIV rapid test for confirmatory testing in national testing algorithms across developing countries
• TrinScreen
• Premier Hb9210
• Premier Resolution
• epiCapture
• PrePsia
• Trinovium
• CGM+
• Captia
• ImmuGlo
• ImmuLisa
• MarDx
• Bartels

Products and services

• Premier Hb9210 HbA1c Analyser FDA 510(k) cleared HPLC analyser employing patented boronate affinity technology for quantitative measurement of HbA1c in human capillary and venous whole blood, used for monitoring long-term glycemic control in diabetes patients. Achieved IFCC Gold Classification for 2026 with 48 tests per hour throughput and 75-second analysis time.
• Premier Resolution FDA 510(k) cleared ion-exchange HPLC analyser delivering automated haemoglobin separation with calibrated A2/F for detection of common and rare haemoglobin variants including HbS, HbC, HbD-Los Angeles, and HbE.
• Uni-Gold HIV WHO-prequalified rapid immunoassay for qualitative detection of antibodies to HIV-1 and HIV-2 in serum, plasma, and whole blood. Used as confirmatory test in national HIV testing algorithms across developing countries, providing results in approximately 10 minutes.
• TrinScreen HIV WHO-prequalified rapid immunoassay for qualitative detection of antibodies to HIV-1 and HIV-2, optimized for first-line screening position in HIV testing algorithms. Reduces turnaround time by approximately 33% compared to leading HIV screening tests.
• CGM+ Continuous Glucose Monitoring Platform AI-native wearable biosensor platform combining continuous glucose monitoring with heart activity, body temperature, and physical activity tracking in a modular wearable device. Real-time AI analysis for personalized, predictive, and preventative care with a needle-free sensor design and 15-day wear period.
• EpiCapture Prostate Cancer Test PCR-based epigenetic liquid biopsy test using machine learning to analyze DNA biomarkers from urine samples for risk prediction of aggressive prostate cancer. Achieved 85% accuracy in clinical validation and is designed to reduce reliance on MRI scans and biopsies.
• PrePsia Preeclampsia Test Early pregnancy preterm preeclampsia risk assessment test using proprietary machine learning algorithms combined with metabolomics technology and placental growth factor analysis. Intended for singleton pregnancies at 11+0 to 13+6 weeks gestation.
• Trinovium Subsidiary offering dielectric fluid and fluid intelligence systems for liquid-cooled AI data centers, with direct-to-chip liquid cooling formulations and a fluid health monitoring platform using electrochemical sensing and mass spectrometry.
• Captia ELISA Tests Comprehensive range of enzyme-linked immunosorbent assays for detection of antibodies to infectious diseases including HSV, CMV, EBV, measles, mumps, rubella, VZV, Toxo, H. pylori, Chlamydia, Syphilis, Malaria, Legionella, Mycoplasma, Borrelia, and others.
• ImmuGlo IFA Tests Comprehensive range of indirect immunofluorescence antibody tests for autoimmune diagnostics including ANA, anti-dsDNA, ENA profile, anti-mitochondrial, anti-smooth muscle, anti-endomysial, ANCA, thyroid antibodies, and others.
• ImmuLisa ELISA Tests ELISA tests for detection of autoimmune antibodies including celiac tTG IgA/IgG, ENA panel (Sm, RNP, SS-A, SS-B), dsDNA, histone, MPO, PR3, RF IgA/IgG/IgM, and thyroid antibodies.
• Trep-Sure Syphilis Test Qualitative enzyme immunoassay for detection of Treponema pallidum antibodies in human serum or plasma, used as initial screening or confirmatory diagnostic test for syphilis.
• Immco Diagnostics Reference Laboratory New York State-based clinical reference laboratory offering specialized diagnostic testing services including preeclampsia testing, autoimmune testing, and laboratory developed tests such as the enhanced EpiCapture prostate cancer test.

Quantifiable outcome

• Q1 2026 revenue of $10.8 million representing 43% year-on-year increase
• +4 more outcomes

Named customers2 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability10 records

Feature6 records

Partnerships

Six partnerships are on record, tiered strategic, minor and core.

• University at BuffalostrategicStrategic or Co-development Partner · 18 March 2026Trinity Biotech announced collaboration with the University at Buffalo to develop and commercialize novel biomarkers for early detection of Sjögren's Syndrome, an autoimmune disorder affecting millions in the United States. The partnership aims to improve diagnosis speed and accuracy, especially in seronegative patients.
• Bioinformatics Company (for EpiCapture)strategicTechnology or Integration · 14 November 2025Trinity Biotech announced a strategic collaboration with a bioinformatics company to develop advanced analysis techniques for their PCR-based epigenetic liquid biopsy test, EpiCapture, for prostate cancer monitoring.
• Novus DiagnosticsminorStrategic or Co-development Partner · 27 November 2024Trinity Biotech made a strategic investment of $2.5 million in Novus Diagnostics, acquiring a 12.5% equity stake to accelerate development and commercialization of Novus' 15-minute point-of-care sepsis test.
• BayerstrategicStrategic or Co-development Partner · 1 January 2024Trinity Biotech signed a non-binding Letter of Intent with Bayer regarding introduction of CGM biosensor devices in China and India markets, representing potential strategic distribution partnership for the CGM+ platform.
• WaveForm Technologies Inc.coreStrategic or Co-development Partner · 1 January 2024Trinity Biotech acquired the biosensor assets of WaveForm Technologies Inc. and intends to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring product (CGM+).
• Metabolomic DiagnosticscoreStrategic or Co-development Partner · 1 January 2024Trinity Biotech acquired Metabolomic Diagnostics, an in-house diagnostics innovation laboratory specialized in combining advanced biomarker analyses with machine learning to create novel diagnostic solutions including PrePsia.

Scale indicators16 records

Recent moves6 records

Expansion highlights7 records

Direct peers

• Bio-Rad Laboratories: Established diagnostics company with a comparable HPLC-based HbA1c testing portfolio (D-100, Variant II analyzers) and broad clinical diagnostics menu. Directly competes with Trinity Biotech's Premier Hb9210 in the HbA1c and hemoglobinopathy testing market, with significantly larger scale.
• Chembio Diagnostics: Specialized point-of-care diagnostics company with WHO-prequalified HIV rapid tests (DPP HIV-Syphilis, DPP HIV 1/2) and emerging infectious disease tests. Direct competitor in global HIV rapid test procurement markets and similar scale/market positioning to Trinity Biotech's HIV franchise.
• QuidelOrtho: Diversified IVD company spanning immunoassay, molecular diagnostics, and rapid tests including HIV, autoimmune, and infectious disease panels. Overlaps directly with Trinity Biotech's autoimmune IFA/ELISA menu (ImmuGlo, ImmuLisa) and infectious disease ELISA portfolio (Captia).
• DiaSorin: Italian-headquartered specialty IVD company focused on immunodiagnostics and molecular diagnostics with HbA1c testing offerings. Comparable business model with similar specialty diagnostics focus and European manufacturing footprint; directly competes in HbA1c and infectious disease serology.
• OraSure Technologies: Point-of-care diagnostics company specializing in HIV, hepatitis C, and substance abuse testing with strong presence in public health and consumer markets. Direct competitor in HIV rapid testing with comparable scale and similar dependence on government/global health procurement.
• Sekisui Diagnostics: Clinical chemistry and immunoassay diagnostics company offering HIV tests, coagulation, and specialty infectious disease assays. Comparable in portfolio breadth across infectious disease and clinical chemistry, with similar B2B laboratory customer base.

Broad incumbents

• Abbott Laboratories: Global diagnostics leader with overlapping presence in HIV rapid tests (Determine, Binax), CGM (FreeStyle Libre), and core laboratory diagnostics. While much larger and diversified, Abbott competes directly with Trinity Biotech's CGM+ ambitions and HIV testing franchise; key strategic comparison point for the CGM+ opportunity.
• Dexcom: Market-leading continuous glucose monitoring company with widely adopted G6/G7 CGM systems and approximately $9B market cap. Represents the most direct competitive benchmark for Trinity Biotech's CGM+ platform development and commercialization trajectory.

Emerging players

• MDxHealth: Specialized molecular diagnostics company with epigenetic prostate cancer tests (ConfirmMDx, SelectMDx). Closely comparable to Trinity Biotech's EpiCapture prostate cancer liquid biopsy in target indication, biomarker approach (epigenetic/methylation), and commercial pathway (urology channel).

Regional players

• ImmunoScience (SD Biosensor / Abbott): South Korean IVD manufacturer with strong HIV rapid test portfolio and WHO prequalifications, particularly active in Asian and emerging market procurement channels. Comparable to Trinity Biotech's HIV testing franchise with similar WHO prequalification strategy and emerging market distribution focus.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/trinitybiotech
• LinkedInlinkedin.com/company/trinity-biotech

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles16 records

Subsidiaries4 records

Funding overview

Funding rounds9 records

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A9 records

Investments3 records

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Trinity Biotech