9. Molecular Diagnostics Laboratory

Brief Introduction

The Molecular Diagnostics Laboratory supports the translation of academic and clinical research (RUO – Research Use Only) into Laboratory Developed Tests and Services (LDTs), facilitating precision medicine applications and accelerating commercialization.

- Accredited under TAF/ISO 17025.

- Registered with TFDA-LDTs for two validated test items: Mycoplasma detection and EGFR mutation testing.

- Serves as a core molecular diagnostics laboratory compliant with international regulatory standards.

Scope of Services

Development and implementation of molecular diagnostic assays (including QMS-compliant workflows).

Core Facilities

1. Sample Pre-processing System – Automated extraction and purification of nucleic acids (DNA & RNA) from various clinical specimens.

2. Real-time Nucleic Acid Amplification System – Quantitative molecular amplification for mutation and gene expression analysis.

3. Digital Nucleic Acid Amplification System – High-sensitivity digital quantification of nucleic acid molecules.

4. Micro/Nanoparticle Analysis System – Exosome and extracellular vesicle analysis.

5.Gene Sequencing System – Gene sequencing, mutation identification, and gene expression analysis.