Trinity Biotech Announces Successful Clinical Results for Its Enhanced EpiCapture™ Prostate Cancer Test

Rhea-AI Summary

Trinity Biotech (Nasdaq: TRIB) reported successful clinical results for an enhanced EpiCapture™ urine-based prostate cancer test on March 23, 2026. The upgraded test uses machine learning with added patient features, including ethnicity, and showed an AUC of 85% in a study of ~750 diverse samples. Trinity plans to commercialize EpiCapture as a Laboratory Developed Test through its New York reference laboratory and will submit the data for peer-reviewed publication.

Positive

• AUC 85% clinical accuracy in study
• Study size of ~750 ethnically diverse samples
• Planned U.S. roll-out via New York reference laboratory LDT
• First entry into precision oncology diagnostics

Negative

• Study results not yet peer-reviewed or published
• Commercial launch via LDT may limit some regulatory pathways

Key Figures

US lifetime prostate cancer risk: 1 in 8 men US prostate cancer spend: $20 billion annually Clinical study size: approximately 750 patient samples +1 more

4 metrics

US lifetime prostate cancer risk 1 in 8 men Epidemiology statement for U.S. male population

US prostate cancer spend $20 billion annually U.S. national expenditures for prostate cancer care

Clinical study size approximately 750 patient samples Validation cohort for enhanced EpiCapture test

Clinical accuracy (AUC) 85% Area Under the Curve for upgraded EpiCapture test

Market Reality Check

Price: $0.6367 Vol: Volume 104,802 is 0.44x t...

low vol

$0.6367 Last Close

Volume Volume 104,802 is 0.44x the 20-day average of 239,151, indicating muted trading ahead of this news. low

Technical Shares at $0.6367 are trading below the $0.91 200-day MA and 81.49% below the 52-week high of $3.44.

Peers on Argus

Two healthcare device peers flagged by momentum scanners moved down (median -3.2...

2 Down

Two healthcare device peers flagged by momentum scanners moved down (median -3.2%), suggesting broader sector pressure alongside TRIB’s -2.27% move.

Previous Clinical trial Reports

1 past event · Latest: Aug 12 (Positive)

Same Type Pattern 1 events

Date	Event	Sentiment	Move	Catalyst
Aug 12	CGM+ trial results	Positive	+35.6%	Breakthrough CGM+ clinical results with 15-day, calibration-free sensor performance.

Pattern Detected

Clinical trial updates have previously coincided with strong positive price reactions for TRIB.

Recent Company History

Across recent updates, Trinity Biotech has emphasized pipeline progress, notably the August 12, 2025 breakthrough clinical trial results for its CGM+ sensor, which delivered accurate glucose readings over a 15-day wear period without finger-stick calibration and saw a 35.59% price reaction. Today’s EpiCapture prostate cancer study extends that innovation narrative into precision oncology, adding another clinically validated, data-driven diagnostic asset to the company’s portfolio.

Historical Comparison

+35.6% avg move · Past clinical-trial news for TRIB (1 event) saw an average move of +35.59%, highlighting historicall...

clinical trial

+35.6%

Average Historical Move clinical trial

Past clinical-trial news for TRIB (1 event) saw an average move of +35.59%, highlighting historically high sensitivity to validated clinical data.

Earlier tagged events focused on CGM+ glucose-monitoring trials; the current update broadens TRIB’s clinically validated footprint into oncology via the EpiCapture prostate cancer test.

Market Pulse Summary

This announcement details successful clinical validation of the enhanced EpiCapture prostate cancer ...

Analysis

This announcement details successful clinical validation of the enhanced EpiCapture prostate cancer test, showing an 85% AUC across ~750 patient samples in an independent study. It marks TRIB’s first step into precision oncology, complementing earlier CGM+ clinical progress that previously drove a 35.59% move. Investors may track publication of the data, adoption of the LDT through the New York reference lab, and subsequent updates on reimbursement and clinical uptake.

Key Terms

machine learning, biomarkers, liquid biopsy, Area Under the Curve, +4 more

8 terms

machine learning technical

"This next-generation version of EpiCapture™ utilizes machine learning tools that integrate additional patient features..."

Machine learning is a set of computer programs that learn patterns from large amounts of data and improve their predictions or decisions over time, like a recipe that gets better each time it’s adjusted based on taste tests. For investors it matters because these systems can speed up analysis, spot trends or risks humans might miss, automate routine work, and potentially create competitive advantages or cost savings that affect a company’s performance.

biomarkers medical

"in conjunction with the DNA biomarkers, enabling the test to generate more accurate, individualized risk..."

Biomarkers are measurable indicators found in the body, such as substances in blood or tissues, that reveal information about health or disease. For investors, they can signal how well a medical treatment is working or whether a disease is developing, helping to assess the potential success or risks of healthcare companies or innovations. Think of biomarkers as biological signals that provide clues about a person’s health status.

liquid biopsy medical

"EpiCapture, as a urine liquid biopsy test, offers a simpler and more accessible alternative..."

A liquid biopsy is a laboratory test that looks for tiny pieces of tumor or disease-related material — such as DNA, proteins, or cells — circulating in blood or other body fluids, allowing detection and monitoring without a surgical tissue sample. For investors, it matters because these tests can speed diagnosis, guide treatment choices, enable easier repeat testing, and create recurring revenue streams if adopted widely, affecting a medical company's growth and regulatory risk profile.

Area Under the Curve technical

"delivers clinical accuracy (Area Under the Curve, AUC) of 85%—a level considered strong..."

Area under the curve (AUC) is a measure of total exposure to a drug over time, calculated by summing the concentration of the drug in the blood at each point after dosing. For investors, AUC matters because it helps regulators and doctors judge how much of a medicine reaches the body and for how long—information that influences dosing, safety, regulatory approval, and ultimately a drug’s market potential, much like measuring total rainfall tells you how wet a season was.

AUC technical

"clinical accuracy (Area Under the Curve, AUC) of 85%—a level considered strong..."

Area under the curve (AUC) measures the total exposure of the body to a drug over time by calculating the area beneath a plot of drug concentration versus time. For investors, AUC indicates how much of a medicine reaches and stays in the bloodstream, which affects dosing, safety and effectiveness—similar to measuring how much water flows through a pipe over a day rather than just its peak pressure.

Laboratory Developed Test regulatory

"plans to commercialize the EpiCapture test as a proprietary Laboratory Developed Test (LDT)..."

A laboratory developed test is a medical diagnostic created, validated and performed within a single clinical laboratory rather than sold as a boxed product to other labs or clinics. For investors, LDTs can offer faster product rollout and niche revenue streams like a custom service, but they also carry regulatory and reimbursement uncertainty and competitive risk—think of them as a handmade tool that can be quickly offered to customers but may face shifting rules or market limits.

LDT regulatory

"as a proprietary Laboratory Developed Test (LDT) through its New York State Department of Health certified..."

A laboratory-developed test (LDT) is a medical test designed, validated and run within a single clinical laboratory rather than sold as a ready-made kit. Think of it like a custom recipe a bakery creates in-house instead of buying prepackaged mixes; it can provide specialized or faster diagnostics tailored to patients. For investors, LDTs matter because they can drive a lab’s revenue and growth but also carry regulatory, scalability and reimbursement risks that affect a company’s financial outlook.

precision oncology medical

"EpiCapture marks Trinity Biotech’s first entry into the precision oncology diagnostics market..."

Precision oncology uses detailed biological information from a patient’s tumor—like genetic changes or specific markers—to choose treatments most likely to work for that individual, much like tailoring a suit to a person’s measurements instead of selling one-size-fits-all clothing. It matters to investors because these targeted approaches can improve treatment success, support premium pricing and companion diagnostic tests, and shorten development and approval timelines, creating focused markets with both higher potential returns and specialized risks.

AI-generated analysis. Not financial advice.

• Test Now Incorporates Enhanced Machine Learning Risk Prediction Algorithm 
  
• Plans Underway to Commercialise Testing Service Through Trinity Biotech’s New York Reference Laboratory

DUBLIN and NEW YORK, March 23, 2026 (GLOBE NEWSWIRE) -- Trinity Biotech plc (Nasdaq: TRIB), a global diagnostics company, today announced successful results from a clinical study of a new, enhanced version of its EpiCapture™ prostate cancer test, engineered to deliver higher precision risk prediction of aggressive prostate cancer.

This next-generation version of EpiCapture™ utilizes machine learning tools that integrate additional patient features, including patient ethnicity in conjunction with the DNA biomarkers, enabling the test to generate more accurate, individualized risk prediction scores. This enhanced approach addresses a well-documented challenge in oncology diagnostics: meaningful performance variation across different demographic and ethnic groups, particularly in prostate cancer where incidence and severity differ significantly among populations.

A Less Invasive, More Accessible Diagnostic Pathway

EpiCapture, as a urine liquid biopsy test, offers a simpler and more accessible alternative to traditional diagnostic methods for assessing high-grade prostate cancer risk. Current approaches — including high resolution MRI scans, which are often costly and limited in availability, and needle biopsies, which may expose patients to infection risk and other complications — present significant barriers to early and accessible detection.

Prostate cancer is the most common non-skin cancer among men in the U.S., with about 1 in 8 men diagnosed during their lifetime and U.S. national expenditures for prostate cancer care recently estimated to be over $20 billion annually¹. The ability to accurately monitor prostate cancer progression is critical, as the disease can often be slow-growing, and unnecessary invasive interventions, such as prostate biopsies, can lead to significant complications.

Clinical Validation Across 750 Patient Samples

The performance of the upgraded test was evaluated in a comprehensive clinical study involving approximately 750 patient samples, representing a substantially larger and more ethnically diverse cohort than EpiCapture’s earlier studies. The study was conducted independently by a specialist bioinformatics research partner, to ensure rigorous and independent validation of the diagnostic performance obtained with the next-generation EpiCapture™ algorithm.

Results from this latest study indicate that the new version of the EpiCapture™ test delivers clinical accuracy (Area Under the Curve, AUC) of 85%—a level considered strong and clinically useful within the oncology diagnostics field. These data underscore the potential of EpiCapture™ to improve early identification of patients at risk of aggressive prostate cancer, enabling more informed clinical decision making and personalized care pathways.

These findings will now be submitted for publication in a peer reviewed oncology journal.

Commercialization Pathway

Trinity Biotech plans to commercialize the EpiCapture test as a proprietary Laboratory Developed Test (LDT) through its New York State Department of Health certified diagnostics reference laboratory. This strategy allows for the rapid roll-out of this precision oncology testing service to patients across the U.S.

A Strategic Entry into Oncology and Precision Medicine

EpiCapture marks Trinity Biotech’s first entry into the precision oncology diagnostics market, representing a significant milestone in the Company’s strategic evolution toward precision medicine applications. The development of the enhanced EpiCapture test reflects Trinity Biotech’s commitment to leveraging its scientific expertise, bioinformatics capabilities, and clinical infrastructure to address unmet needs in high burden disease areas.

John Gillard, President and Chief Executive Officer of Trinity Biotech, commented:
“The enhanced EpiCapture test represents a major step forward for prostate cancer risk prediction and underscores further significant progress in our broader innovation agenda. This is a strong example of how we are expanding into precision medicine and building a portfolio of advanced, multimodal, data driven diagnostics, including expanding the innovation capabilities of our New York reference laboratory.”

Dr Antoinette Perry, Associate Professor in Cell & Molecular Biology, University College Dublin, commented:
“The results of this multi-centre study demonstrate strong performance and establish the technology as a first-in-field biomarker test to incorporate ethnicity as a key variable within its predictive algorithm. Prostate cancer incidence and outcomes vary significantly across different geographic and ethnic populations, yet the biological drivers underlying these differences remain incompletely understood.”

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, 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.

¹ https://progressreport.cancer.gov/after/economic_burden

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

FAQ

What were the March 23, 2026 EpiCapture clinical results announced by TRIB?

The enhanced EpiCapture test achieved an AUC of 85% for aggressive prostate cancer risk prediction. According to the company, this result came from an independent study of approximately 750 ethnically diverse patient samples.

How will TRIB commercialize the enhanced EpiCapture test in the U.S.?

Trinity plans to offer EpiCapture as a proprietary Laboratory Developed Test (LDT) through its New York reference laboratory. According to the company, this enables a rapid roll-out of the testing service across the U.S.

What clinical advantage does the new EpiCapture algorithm provide for TRIB patients?

The upgraded algorithm integrates ethnicity and additional patient features to improve individualized risk scores. According to the company, this aims to reduce performance variation across demographic groups and improve detection of aggressive disease.

How large and diverse was the clinical study supporting TRIB's EpiCapture upgrade?

The validation involved approximately 750 patient samples, described as substantially larger and more ethnically diverse than prior studies. According to the company, the study was conducted independently by a specialist bioinformatics partner.

Has TRIB published the EpiCapture study in a peer-reviewed journal yet?

No, the company said the findings will be submitted for peer-reviewed publication and are not yet published. According to Trinity, submission to an oncology journal is planned following the independent study.