Industrial Technology Research Institute

Technology Overview

ITRI has established a molecular testing laboratory and medical device GMP manufacturer, offering Lab-Developed Tests (LDTs) and trial production services for clinical diagnostic devices and reagents. This enables prototype products to gain regulatory recognition and thus accelerates their commercialization progress.

Furthermore, ITRI has developed a liquid biopsy malignant tumor diagnostic technology and automatic testing system. This system only requires blood samples to detect the EGFR gene mutation for lung cancer patients and provide results for clinical treatment. Compared to existing products, the Imagestechnology allows blood samples to be stored and transported at room temperature and halves the cell-free nucleic acid processing time for samples. In addition, this technology is also able to locate EGFR mutations in eight different methods in total, one more than the current seven.

Applications & Benefits

Through LDTs and relevant clinical data, ITRI will connect the upstream raw material supply, midstream testing reagents, and downstream system industries to boost the development of diagnostic and testing technologies.

One-Stop Biomedical Services

• Listing Regulations Consulting: FDA/TFDA/CE application, medical device verification/export, medical device/medicine registration, IRB document organization, clinical trial application, and more.
• Technology Transfer: Bio-IT, diagnostics and precision medicine technology, regeneration medicine technology, natural medicine and healthcare technology, targeted drug and delivery technology.
• Model Translation: Domestic supply chain linkage, medical device design control, market analysis, strategy analysis of regulation in commercialization, and more.
• Preclinical / Clinical Trial: Functional safety assessments, clinical research organization linkage, clinical evaluation and analysis, clinical trial planning, clinical trial analysis and reports.
• Other Services: Quality system consulting, commercialization consulting, smart health solutions, software validation, medical device risk management, information security risk evaluation, technical documents preparation, business ecosystem linkage, and more.