Trinity Biotech Receives Regulatory Approval to Begin FDA-Cleared PreClara™ Preeclampsia Testing Service
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Aug 14 2025
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Should l Buy TRIB?
Source: Newsfilter
Regulatory Approval: Trinity Biotech's New York laboratory has received regulatory approval to provide the FDA-cleared PreClara™ Ratio biomarker test for assessing preeclampsia risk, marking a significant advancement in maternal health diagnostics.
Impact on Maternal Health: The PreClara™ test aims to improve care for approximately 500,000 women affected by hypertensive pregnancy disorders annually in the U.S., potentially saving over $10 million in neonatal costs per 1,000 patients through reduced preterm deliveries and NICU admissions.
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Analyst Views on TRIB
About TRIB
Trinity Biotech plc 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. The products are used to detect infectious diseases and to quantify the level of Hemoglobin A1c and other chemical parameters in serum, plasma and whole blood, and the Company intends to develop a range of biosensor devices and related services, starting with a continuous glucose monitoring product. Its TrinScreen Human Immunodeficiency Virus (HIV) rapid point-of-care test is a high-quality, single-use immunoassays to aid in the diagnosis of HIV. The Uni-Gold range of rapid point-of-care test devices consist of high-quality, single-use immunoassays to aid in the diagnosis of HIV.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Trinity Biotech Receives Regulatory Approval for New Production Model Launch
- Regulatory Milestone: Trinity Biotech has received local regulatory approval, marking the initiation of upstream manufacturing activities for its Uni-Gold™ HIV rapid test under a new outsourced production model, which is a key component of the company's comprehensive transformation plan.
- Cost Efficiency Improvement: The implementation of the offshore and outsourced production model is expected to significantly enhance gross margins and improve working capital efficiency, thereby strengthening the company's long-term competitiveness in the global HIV rapid testing market.
- Market Demand Support: This transition will not only meet the anticipated growth in demand for Uni-Gold™ HIV products but also provide the necessary scalability to ensure the company remains agile and responsive in a rapidly changing market environment.
- Strategic Transformation Plan: This approval complements the WHO authorization obtained in November 2025, demonstrating the company's strong commitment to executing its comprehensive transformation plan, which is expected to lay a solid foundation for future financial performance.
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- Financing Agreement: The company entered into a securities purchase agreement with investor David E. Lazar on December 22, 2025, selling 1 million shares of convertible preferred stock for $6 million, which is expected to provide financial support pending shareholder approval.
- Positive Market Reaction: Trinity Biotech's stock surged 43.50% to $1.28 after announcing a significant HIV testing order, reflecting market optimism regarding its financial stability and demand recovery.
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- Accelerated GDP Growth: The U.S. GDP grew at an annualized rate of 4.3% in the third quarter, up from 3.8% in the previous quarter and exceeding market estimates of 3.3%, indicating potential for economic recovery that may positively influence the stock market.
- Mixed Sector Performance: Communication services rose by 0.5% while consumer staples fell by 0.5%, demonstrating varied market reactions across sectors, prompting investors to monitor industry dynamics for strategic adjustments.
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- Slight Industrial Production Increase: U.S. industrial production rose by 0.1% month-over-month in October and November, suggesting stability in manufacturing, which may support ongoing economic growth despite the modest increase.
- Decline in Durable Goods Orders: Durable goods orders fell by 2.2% month-over-month to $307.4 billion in October, reflecting a cautious stance among businesses amid uncertainties, which could impact future production plans and economic outlook.
- Mixed Market Reactions: Despite positive economic data, stock market performance was mixed, with the Nasdaq rising by 0.2% while the Dow dipped slightly, indicating varied investor responses across different sectors that may influence short-term market sentiment.
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- Financial Restructuring: The company announced new financing agreements that include additional term loan funding and greater flexibility to settle obligations through equity, alleviating near-term cash strain and extending debt maturities to 2027, thereby supporting its turnaround strategy.
- Performance Rebound: Recent quarterly results show sequential revenue growth driven by increased sales of HIV rapid tests and hemoglobin products, with adjusted EBITDA turning positive, marking a significant reversal in the company's restructuring efforts.
- Leadership Change: Paul Murphy has stepped into the role of interim CFO following Susan O'Connor's term, indicating ongoing stability in key management as the company aims to support its international expansion and commercialization of new products.
See More
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Positive Financial Update: The company reported a 32% increase in Q3 2025 revenues to $14.3 million, with gross profit rising to $6.5 million and adjusted EBITDA improving to $0.5 million, leading to a 50% increase in share price during pre-market trading.
See More
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- Regulatory Milestone: Trinity Biotech has received local regulatory approval, marking the initiation of upstream manufacturing activities for its Uni-Gold™ HIV rapid test under a new outsourced production model, which is a key component of the company's comprehensive transformation plan.
- Cost Efficiency Improvement: The implementation of the offshore and outsourced production model is expected to significantly enhance gross margins and improve working capital efficiency, thereby strengthening the company's long-term competitiveness in the global HIV rapid testing market.
- Market Demand Support: This transition will not only meet the anticipated growth in demand for Uni-Gold™ HIV products but also provide the necessary scalability to ensure the company remains agile and responsive in a rapidly changing market environment.
- Strategic Transformation Plan: This approval complements the WHO authorization obtained in November 2025, demonstrating the company's strong commitment to executing its comprehensive transformation plan, which is expected to lay a solid foundation for future financial performance.
See More
Indaptus Therapeutics Stock Soars 64.65% to $3.26 After Securities Agreement
- Significant Stock Movement: Indaptus Therapeutics saw its stock decline 2.46% to $1.98 at close but surged 64.65% to $3.26 in after-hours trading, indicating strong investor confidence in its future potential.
- Financing Agreement: The company entered into a securities purchase agreement with investor David E. Lazar on December 22, 2025, selling 1 million shares of convertible preferred stock for $6 million, which is expected to provide financial support pending shareholder approval.
- Positive Market Reaction: Trinity Biotech's stock surged 43.50% to $1.28 after announcing a significant HIV testing order, reflecting market optimism regarding its financial stability and demand recovery.
- Pipeline Restart Approval: Sable Offshore's shares rose 36.32% to $10.36 following the U.S. Pipeline and Hazardous Materials Safety Administration's approval of the Las Flores Pipeline system restart plan, marking a critical step forward in the company's operational recovery.
See More
Dow Jones Index Gains Over 100 Points as Durable Goods Orders Decline 2.2%
- Dow Jones Index Rise: The Dow Jones index increased by over 100 points on Tuesday, closing at 48,469.41, indicating a moderate market recovery despite disappointing economic data.
- Durable Goods Orders Decline: U.S. durable goods orders fell by 2.2% month-over-month to $307.4 billion in October, significantly missing market expectations of a 1.5% decline, reflecting weak manufacturing demand that could impact future economic growth.
- Accelerated GDP Growth: The U.S. GDP grew at an annualized rate of 4.3% in the third quarter, up from 3.8% in the previous quarter and exceeding market estimates of 3.3%, indicating potential for economic recovery that may positively influence the stock market.
- Mixed Sector Performance: Communication services rose by 0.5% while consumer staples fell by 0.5%, demonstrating varied market reactions across sectors, prompting investors to monitor industry dynamics for strategic adjustments.
See More
U.S. GDP Grows 4.3% Annually, Highest in Two Years
- Accelerated Economic Growth: The U.S. GDP grew at an annualized rate of 4.3% in Q3, a significant increase from 3.8% in the previous quarter and surpassing market expectations of 3.3%, indicating a robust economic recovery that could drive future investment and consumer spending.
- Slight Industrial Production Increase: U.S. industrial production rose by 0.1% month-over-month in October and November, suggesting stability in manufacturing, which may support ongoing economic growth despite the modest increase.
- Decline in Durable Goods Orders: Durable goods orders fell by 2.2% month-over-month to $307.4 billion in October, reflecting a cautious stance among businesses amid uncertainties, which could impact future production plans and economic outlook.
- Mixed Market Reactions: Despite positive economic data, stock market performance was mixed, with the Nasdaq rising by 0.2% while the Dow dipped slightly, indicating varied investor responses across different sectors that may influence short-term market sentiment.
See More
Trinity Biotech Secures 9M HIV Test Order, Stock Surges 69.28%
- Order Recovery: Trinity Biotech has secured a commitment for 9 million units of its TrinScreen rapid HIV test, expected for delivery between late 2025 and early 2026, indicating a resurgence in procurement activity from global health organizations and enhancing revenue visibility for the company.
- Financial Restructuring: The company announced new financing agreements that include additional term loan funding and greater flexibility to settle obligations through equity, alleviating near-term cash strain and extending debt maturities to 2027, thereby supporting its turnaround strategy.
- Performance Rebound: Recent quarterly results show sequential revenue growth driven by increased sales of HIV rapid tests and hemoglobin products, with adjusted EBITDA turning positive, marking a significant reversal in the company's restructuring efforts.
- Leadership Change: Paul Murphy has stepped into the role of interim CFO following Susan O'Connor's term, indicating ongoing stability in key management as the company aims to support its international expansion and commercialization of new products.
See More
Trinity Biotech Shares Increase Following 9M TrinScreen HIV Test Order
Order for HIV Screening Product: Trinity Biotech has received an order for 9 million units of its TrinScreen HIV product, which will be produced using a newly approved WHO manufacturing process, expected to fulfill by late 2025 to early 2026.
Positive Financial Update: The company reported a 32% increase in Q3 2025 revenues to $14.3 million, with gross profit rising to $6.5 million and adjusted EBITDA improving to $0.5 million, leading to a 50% increase in share price during pre-market trading.
See More
