Applications and regulatory of nanotechnology‐based innovative in vitro diagnostics
Kuan Chen,
Houyu Han,
Ruslan G. Tuguntaev,
Peirong Wang,
Weisheng Guo,
Jiayu Huang,
Xiaoqun Gong,
Xing‐Jie Liang
Affiliations
Kuan Chen
Center for Medical Device Evaluation National Medical Products Administration Beijing China
Houyu Han
School of Life Sciences Tianjin University and Tianjin Key Laboratory of Function and Application of Biological Macromolecular Structures Tianjin China
Ruslan G. Tuguntaev
Translational Medicine Center, State Key Laboratory of Respiratory Disease, The Second Affiliated Hospital Guangzhou Medical University Guangzhou China
Peirong Wang
Center for Medical Device Evaluation National Medical Products Administration Beijing China
Weisheng Guo
Translational Medicine Center, State Key Laboratory of Respiratory Disease, The Second Affiliated Hospital Guangzhou Medical University Guangzhou China
Jiayu Huang
School of Life Sciences Tianjin University and Tianjin Key Laboratory of Function and Application of Biological Macromolecular Structures Tianjin China
Xiaoqun Gong
School of Life Sciences Tianjin University and Tianjin Key Laboratory of Function and Application of Biological Macromolecular Structures Tianjin China
Xing‐Jie Liang
Laboratory of Controllable Nanopharmaceuticals, Chinese Academy of Sciences (CAS) Center for Excellence in Nanoscience and CAS Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety National Center for Nanoscience and Technology of China Beijing China
Abstract Nanotechnology‐basedin vitro diagnostics (nanoIVDs) are widely studied for disease diagnostics with promising sensitivity, specificity, and convenience. However, it is still a major challenge for both regulatory authorities and scientific researchers to accelerate the clinical translation of such an innovative technology. Herein, this perspective discussed the benefits and challenges of nanoIVDs as well as the administration considerations on the distinguish features of nanoIVDs by regulatory authorities, so as to further achieve the evaluation, translation, and application of nanoIVD products.
