Trinity Biotech (TRIB) reports successful EpiCapture prostate cancer trial and commercialization plan
Filing Impact
Filing Sentiment
Form Type
6-K
Rhea-AI Filing Summary
Trinity Biotech plc announced successful clinical study results for an enhanced version of its EpiCapture™ prostate cancer test and outlined commercialization plans, while also obtaining a limited waiver under its Credit Agreement. The upgraded urine-based test now uses a machine learning algorithm that integrates DNA biomarkers with patient features such as ethnicity to improve individualized risk prediction for aggressive prostate cancer.
In an independently conducted study of approximately 750 patient samples, the next-generation EpiCapture™ achieved a clinical accuracy (AUC) of 85%, a level described as strong and clinically useful in oncology diagnostics. Trinity Biotech plans to launch EpiCapture™ in the U.S. as a proprietary Laboratory Developed Test through its New York reference laboratory, marking its first entry into precision oncology diagnostics. The company also disclosed that, under the limited waiver for covenant 8.15 with Perceptive Credit Holdings III, interest accruing in March 2026 will be capitalized and added to the principal balance of its debt.
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Insights
Trinity Biotech advances into precision oncology with validated EpiCapture test and modest debt flexibility.
The disclosure shows Trinity Biotech strengthening its diagnostics pipeline through an enhanced EpiCapture™ prostate cancer test. An independently run study on about 750 samples reported an AUC clinical accuracy of 85%, suggesting clinically meaningful performance for identifying aggressive prostate cancer risk.
The company plans to commercialize EpiCapture™ as a Laboratory Developed Test via its New York reference lab, providing a concrete route to U.S. market access in precision oncology. Management also highlights this as a strategic step into oncology and data-driven diagnostics, complementing its broader diagnostic and biosensor portfolio.
On the financing side, a limited waiver on covenant 8.15 of its Credit Agreement with Perceptive Credit Holdings III allows interest accruing in March 2026 to be capitalized and added to principal. This offers short-term balance-sheet flexibility but implies slightly higher future debt obligations. Subsequent filings may provide more detail on adoption, reimbursement, and revenue contribution from EpiCapture™.
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
F O R M 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of March 2026
TRINITY BIOTECH PLC
(Name of Registrant)
IDA Business Park
Bray, Co. Wicklow, Ireland
(Address of Principal Executive Office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
This Form 6-K is being incorporated by reference into our Registration Statements on Form S-8 (File Nos. 333-182279, 333-195232 and 333-253070).
EXPLANATORY NOTE
On March 23, 2026, the Company issued a press release announcing successful clinical trial results for its enhanced EpiCapture™ Prostate Cancer test. A copy of the press releases is filed herewith as Exhibit 99.1.
The Company has also obtained a limited waiver in respect of covenant 8.15 of its Credit Agreement with Perceptive Credit Holdings III.
Interest accruing in March 2026 will be capitalised and added to the principal balance of the debt.
EXHIBIT INDEX
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Exhibit
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Description
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99.1
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Trinity Biotech Announces Successful Clinical Results For Its Enhanced Epicapture™
Prostate Cancer Test
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
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TRINITY BIOTECH PLC
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Trinity Biotech plc
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(Registrant)
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By:
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/s/ Paul Murphy
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Paul Murphy
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Interim Chief Financial Officer
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Date: March 25, 2026
Exhibit 99.1
| Contact: | Trinity Biotech plc | RedChip Companies Inc. |
| Gary Keating, PhD | Dave Gentry, CEO | |
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(353)-1-2769800
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(1)-407-644-4256 | |
| (1)-800-RED-CHIP (733-2447) | ||
| TRIB@redchip.com |
Trinity Biotech Announces Successful Clinical Results For Its
Enhanced Epicapture™ Prostate Cancer Test
- Test Now Incorporates Enhanced Machine Learning Risk Prediction Algorithm
- Plans Underway To Commercialise Testing Service Through Trinity Biotech’s New York Reference Laboratory
DUBLIN, Ireland and New York, United States of America (March 23, 2026) - 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.
1 https://progressreport.cancer.gov/after/economic_burden
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.
FAQ
What did Trinity Biotech (TRIB) announce about its enhanced EpiCapture prostate cancer test?
Trinity Biotech announced successful clinical study results for an enhanced EpiCapture™ prostate cancer test delivering improved risk prediction of aggressive disease. The upgraded urine-based liquid biopsy uses machine learning to combine DNA biomarkers with patient features, aiming for more accurate, individualized risk scores across diverse populations.
How strong were the clinical results reported for Trinity Biotech (TRIB) EpiCapture test?
The enhanced EpiCapture™ test achieved clinical accuracy, measured as Area Under the Curve (AUC), of 85% in an independently conducted study of approximately 750 patient samples. This performance is described as strong and clinically useful within oncology diagnostics, supporting potential use in guiding prostate cancer risk assessment and care decisions.
How does Trinity Biotech (TRIB) plan to commercialize the EpiCapture prostate cancer test?
Trinity Biotech plans to commercialize EpiCapture™ as a proprietary Laboratory Developed Test through its New York State Department of Health certified diagnostics reference laboratory. This approach enables roll-out of the precision oncology testing service to patients across the U.S., without relying initially on traditional in vitro diagnostic kit approvals.
Why is EpiCapture important to Trinity Biotech (TRIB) strategic direction?
EpiCapture™ represents Trinity Biotech’s first entry into the precision oncology diagnostics market, marking a significant strategic milestone. Management positions the enhanced test as part of a broader shift toward advanced, multimodal, data-driven diagnostics and precision medicine applications, alongside the company’s existing diabetes and infectious disease diagnostic franchises.
What financing update did Trinity Biotech (TRIB) provide regarding its credit agreement?
Trinity Biotech reported obtaining a limited waiver related to covenant 8.15 of its Credit Agreement with Perceptive Credit Holdings III. Under this waiver, interest accruing in March 2026 will be capitalized and added to the principal balance of the debt, slightly increasing future repayment obligations while easing near-term cash interest outflow.
How does the EpiCapture test address ethnic differences in prostate cancer risk for TRIB?
The enhanced EpiCapture™ test integrates patient ethnicity and other features with DNA biomarkers in a machine learning algorithm. This design targets performance variation across demographic and ethnic groups, aiming for more equitable and accurate prostate cancer risk predictions where incidence and severity differ significantly between populations.
Filing Exhibits & Attachments
1 documentPress Releases
Trinity Biotech Plc