Trinity Biotech
- Country
- Ownership
- -
- Employees
- 380
- Market Cap
- -
- Introduction
Trinity Biotech Plc engages in the development, manufacture, and marketing of medical diagnostic products for the clinical laboratory and point-of-care segments of the diagnostic market. It operates through the Americas and Rest of World geographical segments. The company was founded by Ronan O'Caoimh and Denis R. Burger in June 1992 and is headquartered in Bray, Ireland.
Clinical Trials
2
Trial Phases
0 Phases
Drug Approvals
0
Drug Approvals
No drug approvals found
This company may not have drug approvals in our database
Clinical Trials
99th Percentile Upper Reference Limit (URL) for the Meritas Troponin I Test
- Conditions
- Acute Coronary Syndrome
- First Posted Date
- 2015-12-23
- Last Posted Date
- 2015-12-23
- Lead Sponsor
- Trinity Biotech
- Target Recruit Count
- 769
- Registration Number
- NCT02638311
- Locations
- 🇺🇸
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
🇺🇸Medical Research South, Charleston, South Carolina, United States
🇺🇸Tanner Clinic, Layton, Utah, United States
Clinical Study to Validate the Use of a New Point of Care Troponin I Test
- Conditions
- Acute Coronary Syndrome
- First Posted Date
- 2015-12-03
- Last Posted Date
- 2015-12-15
- Lead Sponsor
- Trinity Biotech
- Target Recruit Count
- 1500
- Registration Number
- NCT02620397
- Locations
- 🇺🇸
San Francisco General Hospital & Trauma Center, San Francisco, California, United States
🇺🇸University of Florida, Gainesville, Florida, United States
🇺🇸Eastern Idaho Regional Medical Center, Idaho Falls, Idaho, United States
News
Trinity Biotech Receives WHO Approval for Offshore Manufacturing of HIV Rapid Test
Trinity Biotech received World Health Organization approval for offshored and outsourced upstream manufacturing of its TrinScreen HIV rapid test, marking a critical milestone in the company's transformation plan.
Trinity Biotech's CGM Demonstrates Landmark Accuracy Gains in Pre-Pivotal Trial
• Trinity Biotech's next-generation CGM system shows significant first-day accuracy improvements, with a 35% MARD improvement and a 50% MAD improvement. • The pre-pivotal trial included 30 participants with Type 1 diabetes, demonstrating superior signal quality and enhanced reliability post-insertion. • Trinity Biotech's CGM system is designed for affordability and sustainability, featuring reusable components and a user-friendly design. • Regulatory submissions in Europe are expected in 2025, followed by a U.S. FDA filing in 2026, targeting both diabetes patients and health-conscious consumers.
Trinity Biotech's Next-Generation CGM Shows Positive Pre-Pivotal Trial Results
• Trinity Biotech's next-generation continuous glucose monitor (CGM) technology demonstrated positive analytical performance in a recent European pre-pivotal clinical trial. • The trial assessed enhancements made since Trinity Biotech acquired the technology, focusing on improvements to accuracy and user experience of the CGM device. • Key modifications, including a reduction in biosensor wire length, led to favorable mean absolute relative difference (MARD) compared to the previous Waveform device. • A second pre-pivotal trial is planned for Q4 2024, setting the stage for a pivotal trial in 2025, as Trinity Biotech aims to capture a significant share of the growing CGM market.