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Trinity Biotech Glucose Monitoring Innovation Achieves Unique Global Recognition: Diabetes Care Premier Hb9210™ HbA1c Analyser Becomes the Only System Awarded Prestigious IFCC Gold Classification for 2026

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Trinity Biotech (Nasdaq: TRIB) announced its Premier Hb9210™ HbA1c Analyser with the next-generation Buffer A Plus column system received the IFCC Gold Classification for 2026, making it the only HbA1c system worldwide to earn Gold status for 2026.

The certification reflects top-tier analytic precision and bias among >200 systems evaluated. Trinity highlights its ~$100 million cumulative investment in diabetes technologies and notes the global laboratory HbA1c market exceeds $2 billion, projected to surpass $3.5 billion by 2030. Senior commercial executives will attend the World Health Expo Feb 10–12, 2026 to discuss these advances.

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Positive

  • IFCC Gold Classification awarded to Premier Hb9210 for 2026
  • Only HbA1c system worldwide to earn Gold status in 2026
  • Trinity reports cumulative diabetes technology investment of ~$100 million
  • Addresses >$2 billion global laboratory HbA1c market projected to exceed $3.5 billion by 2030

Negative

  • None.

Market Reaction

+7.49% $0.86
15m delay 4 alerts
+7.49% Since News
$0.86 Last Price
$0.78 $0.86 Day Range
+$1M Valuation Impact
$16M Market Cap
0.5x Rel. Volume

Following this news, TRIB has gained 7.49%, reflecting a notable positive market reaction. Our momentum scanner has triggered 4 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $0.86. This price movement has added approximately $1M to the company's valuation.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.

Key Figures

HbA1c lab testing market 2025: >$2 billion per year HbA1c market 2030 projection: $3.5 billion IFCC systems evaluated: more than 200 systems +4 more
7 metrics
HbA1c lab testing market 2025 >$2 billion per year Global laboratory HbA1c market value mentioned in release
HbA1c market 2030 projection $3.5 billion Projected global laboratory HbA1c market by 2030
IFCC systems evaluated more than 200 systems HbA1c analytical systems assessed by IFCC
Manufacturers evaluated approximately 60 manufacturers Number of manufacturers in IFCC HbA1c assessment
Diabetes tech investment approximately $100 million Cumulative investment in diabetes care technologies to date
HbA1c lookback period 2–3 months Timeframe of blood glucose levels reflected by HbA1c
HbA1c testing market size $2 billion Expanding HbA1c testing market referenced for Trinity’s positioning

Market Reality Check

Price: $0.8000 Vol: Volume 83,672 vs 20-day a...
low vol
$0.8000 Last Close
Volume Volume 83,672 vs 20-day average 296,418 (relative 0.28x). Trading ahead of the news from a low-activity base. low
Technical Price $0.80 is below 200-day MA $0.91, 76.74% below 52-week high and 66.67% above 52-week low.

Peers on Argus

Peers in Medical Devices showed mixed moves: IRIX -1.33%, NSYS +4.16%, ADGM -7.0...

Peers in Medical Devices showed mixed moves: IRIX -1.33%, NSYS +4.16%, ADGM -7.03%, AIMD -3.09%, PTHL +113.16%. No consistent sector trend aligns with TRIB’s news.

Historical Context

5 past events · Latest: Dec 23 (Positive)
Pattern 5 events
Date Event Sentiment Move Catalyst
Dec 23 Financing agreements Positive +43.5% Liquidity-strengthening agreements with Perceptive including new term loan and equitization.
Dec 23 Commercial win & earnings Positive +43.5% Major 9M-unit HIV test order plus stronger Q3 revenue and margins.
Dec 15 HbA1c rollout expansion Positive -12.2% Regulatory clearances and wider launch of high-capacity HbA1c column system.
Nov 18 Manufacturing approval Positive +0.5% WHO approval for offshored Uni-Gold HIV manufacturing aimed at margin improvement.
Nov 14 R&D collaboration Positive +3.1% Collaboration to advance epigenetic analysis for EpiCapture prostate cancer test.
Pattern Detected

Most recent positive operational or financing news aligned with positive price reactions, with one notable divergence on an HbA1c expansion update.

Recent Company History

Over the past few months, Trinity Biotech reported several strategic steps. A 9 million-unit TrinScreen HIV order and Q3 2025 revenue of $14.3M with 45.2% gross margin coincided with strong positive price reactions. Capital structure agreements with Perceptive, including a $5M term loan and up to $60M elective equitization, also saw large gains. By contrast, a December 2025 announcement expanding the high-capacity HbA1c column rollout into > 10 countries drew a negative move. Today’s IFCC Gold recognition builds on that HbA1c platform trajectory.

Market Pulse Summary

The stock is up +7.5% following this news. A strong positive reaction aligns with the strategic sign...
Analysis

The stock is up +7.5% following this news. A strong positive reaction aligns with the strategic significance of IFCC Gold status for an HbA1c analyser in a > $2B and growing market. Historically, TRIB often showed positive alignment to value-adding news, especially financing and commercial wins. However, investors have also seen dilution risk from sizable convertible obligations and past filings. Any outsized move could be tempered if concerns about leverage, conversion-driven supply, or execution on CGM and HbA1c growth re-emerge.

Key Terms

hba1c, biomarker, continuous glucose monitoring, ai-powered
4 terms
hba1c medical
"The IFCC is the global authority that sets international standards for HbA1c measurement"
A1c (HbA1c) is a blood test that measures how much sugar has stuck to red blood cells over the past two to three months, giving a single number that reflects average blood glucose control—think of it as a running average score for blood sugar. Investors watch A1c because it’s a common clinical measure used to judge whether diabetes drugs, devices or care programs work, influence regulatory approvals, treatment guidelines and market demand.
biomarker medical
"HbA1c measurement, a critical biomarker for blood glucose management in diabetes care"
A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.
continuous glucose monitoring medical
"development of our continuous glucose monitoring innovation, CGM+ that is being designed"
Continuous glucose monitoring is a system that tracks blood sugar levels in real-time throughout the day and night. It provides constant updates, similar to a car's dashboard showing speed and fuel level at all times. For investors, advancements in this technology can signal progress in health monitoring devices, which may influence the growth and valuation of companies in the healthcare sector.
ai-powered technical
"other metabolic health metrics in a single AI-powered device"
"AI-powered" describes technology that uses artificial intelligence to perform tasks, make decisions, or analyze information automatically. It’s similar to having a highly skilled assistant that can learn from data, recognize patterns, and improve over time, helping to make processes faster and more accurate. For investors, this means better insights and more efficient operations, potentially leading to smarter investment choices.

AI-generated analysis. Not financial advice.

– Reinforces Trinity Biotech’s growing position as a key player in diabetes care innovation

– Senior commercial executives of Trinity Biotech are attending the World Health Expo from February 10-12, 2026

DUBLIN, Ireland, Feb. 10, 2026 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a commercial-stage biotechnology company focused on human diagnostics and diabetes management solutions, including wearable biosensors, today announced that its Premier Hb9210™ HbA1c Analyser with its recently launched next-generation Buffer A Plus column system has achieved the prestigious Gold Classification from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) for 2026. This marks a historic milestone as the Premier Hb9210™ HbA1c Analyser is the only HbA1c system worldwide to earn this highest level of HbA1c manufacturer's certification for 2026. 

No system achieved Gold status in 2025, underscoring the significance of Trinity Biotech’s breakthrough. This achievement demonstrates the company’s ability to deliver industry-leading technology innovations that advance diabetes care worldwide.

The next-generation Premier Hb9210™ Buffer A Plus column system, which is used for laboratory testing, builds on a series of recent innovations and enhancements to the Premier Hb9210™ platform, designed to increase usability, minimize operator interaction, and reduce operating costs while continuing to support the highest levels of patient care.

The IFCC is the global authority that sets international standards for HbA1c measurement, a critical biomarker for blood glucose management in diabetes care. HbA1c reflects the average blood glucose level over the past 2–3 months.  The IFCC’s rigorous certification process evaluates more than 200 HbA1c analytical systems from approximately 60 manufacturers, including the largest global diagnostic companies. Systems are ranked based on analytic precision and bias, with Gold representing the pinnacle of performance.

The global market for laboratory HbA1c testing is currently valued at over $2 billion per year and is projected to surpass $3.5 billion by 20301. This anticipated growth is largely due to the rising incidence of diabetes. Senior commercial executives of Trinity Biotech are attending the World Health Expo from February 10-12, 2026 to discuss these and other advancements that strengthen Trinity Biotech’s position in the expanding $2 billion HbA1c testing market.  

_____________________________

1 https://www.maximizemarketresearch.com/market-report/global-hba1c-laboratory-tests-market/81466/

Management Commentary

John Gillard, Trinity Biotech CEO, commented:

“Achieving IFCC Gold Classification is a testament to our core focus on industry-leading innovation, precision, and quality at Trinity Biotech. It further enhances our standing in the broader glucose monitoring market and diabetes care where we already support millions of patients around the world annually with our HbA1c testing technology.

We are deeply committed to diabetes care and broader metabolic health management, with Trinity Biotech’s cumulative investment in our diabetes care technologies already approaching approximately $100 million to date. Central to this commitment is the pioneering development of our continuous glucose monitoring innovation, CGM+ that is being designed to augment glucose monitoring with other metabolic health metrics in a single AI-powered device.

With several exciting R&D milestones anticipated over the course of this year, we are advancing strongly in our mission to help everyone measure and manage metabolic health for healthier, longer lives.”

For more information about Trinity Biotech and the Premier Hb9210™ system, please contact info@trinitybiotech.com

Forward-Looking Statements
This release includes statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Reform Act”), including but not limited to statements related to Trinity Biotech’s cash position, financial resources and potential for future growth, market acceptance and penetration of new or planned product offerings, and future recurring revenues and results of operations. Trinity Biotech claims the protection of the safe harbor for forward-looking statements contained in the Reform Act. These forward-looking statements are often characterized by the terms “may,” “believes,” “projects,” “expects,” “anticipates,” or words of similar import, and do not reflect historical facts. Specific forward-looking statements contained in this release may be affected by risks and uncertainties, including, but not limited to, our ability to capitalize on the Waveform transaction and of our recent acquisitions, our continued listing on the Nasdaq Stock Market, our ability to achieve profitable operations in the future, our ability to reduce our debt and improve our capitalization, the impact of the spread of COVID-19 and its variants, the possible pause and/or disruption in U.S. Government funding for HIV tests produced by Trinity Biotech, potential excess inventory levels and inventory imbalances at the company’s distributors, losses or system failures with respect to Trinity Biotech’s facilities or manufacturing operations, the effect of exchange rate fluctuations on international operations, fluctuations in quarterly operating results, dependence on suppliers, the market acceptance of Trinity Biotech’s products and services, the continuing development of its products, required government approvals, risks associated with manufacturing and distributing its products on a commercial scale free of defects, risks related to the introduction of new instruments manufactured by third parties, risks associated with competing in the human diagnostic market, risks related to the protection of Trinity Biotech’s intellectual property or claims of infringement of intellectual property asserted by third parties and risks related to condition of the United States economy and other risks detailed under “Risk Factors” in Trinity Biotech’s annual report on Form 20-F for the fiscal year ended December 31, 2024 and Trinity Biotech’s other periodic reports filed from time to time with the United States Securities and Exchange Commission. Forward-looking statements speak only as of the date the statements were made. Trinity Biotech does not undertake and specifically disclaims any obligation to update any forward-looking statements.

About Trinity Biotech

Trinity Biotech is a commercial stage biotechnology company focused on diabetes management solutions and human diagnostics, including wearable biosensors. The Company develops, acquires, manufactures and markets diagnostic systems, including both reagents and instrumentation, for the point-of-care and clinical laboratory segments of the diagnostic market and has recently entered the wearable biosensor industry, with the acquisition of 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. Our products are used to detect infectious diseases and to quantify the level of Haemoglobin A1c and other chemistry parameters in serum, plasma and whole blood. Trinity Biotech sells direct in the United States and through a network of international distributors and strategic partners in over 75 countries worldwide. For further information, please see the Company's website: www.trinitybiotech.com.

Contact:Trinity Biotech plcRedChip Companies Inc.
 Gary Keating, Ph.DDave Gentry, CEO
 (353)-1-2769800(1)-407-644-4256
  (1)-800-RED-CHIP (733-2447)
  TRIB@redchip.com

FAQ

What does the IFCC Gold Classification for 2026 mean for Trinity Biotech (TRIB)?

It indicates the Premier Hb9210 met the highest IFCC standards for analytic precision and bias. According to the company, this is the only HbA1c system worldwide awarded Gold for 2026, validating product performance against >200 systems from ~60 manufacturers.

How does the Premier Hb9210 Buffer A Plus update affect laboratory operations for TRIB customers?

The Buffer A Plus column aims to increase usability and reduce operating costs in lab workflows. According to the company, the next-generation system minimizes operator interaction while maintaining high patient-care measurement standards.

What market opportunity does the IFCC Gold award target for Trinity Biotech (TRIB)?

The award positions Trinity to compete in the global lab HbA1c market valued at over $2 billion annually. According to the company, that market is projected to surpass $3.5 billion by 2030, driven by rising diabetes prevalence.

Will Trinity Biotech executives discuss the IFCC Gold Classification at World Health Expo 2026?

Yes. Senior commercial executives will attend the World Health Expo Feb 10–12, 2026 to discuss the achievement and related diabetes care advances. According to the company, the presence aims to strengthen commercial engagement in the HbA1c market.

How much has Trinity Biotech invested in diabetes care technologies including the Premier Hb9210 (TRIB)?

Trinity reports cumulative investment approaching approximately $100 million in diabetes care technologies to date. According to the company, that funding supports innovations like the Premier Hb9210 and development of CGM+ continuous glucose monitoring work.
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