Chapter 5
Aptamer-Based Medical Devices
Boshi Liu, Haixia Wang, and Di Zhang
Abstract Medical devices have undergone an evolution over thousands of years
with the intention to improve the health of people. Aptamers are single-stranded
nucleotides that can specifically bind to their targets. They are promising alternatives
of antibodies in the field of medical devices owing to the property of specific binding
to their targets, as well as the advantages such as easy synthesis and modification,
chemical stability, low immunogenicity, and competitive cost, etc. Nevertheless, to
our knowledge, there are no aptamer-based medical devices officially approved in
the market. Therefore, in this chapter, we first introduced the definition, history,
and market of medical devices. Then, some potentially prototypical aptamer-based
medical devices related clinical trials, patents, and papers were introduced from two
aspects according to their application in “diagnosis” and “therapies,” respectively.
Finally, we proposed our perspectives and insights for the development of aptamerbased medical devices.
Keywords Aptamers · Antibodies · Medical devices · Biomarkers · Diagnosis ·
Therapeutics
5.1 Introduction
Medical devices are healthcare products that do not achieve their purpose by chemical
action or by being metabolized [1]. The U. S. Food and Drug Administration (FDA)
defines a medical device as:
• “an instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent, or other similar or related article, including a component part or accessory
which is: recognized in the official National Formulary, or the United States
Pharmacopoeia, or any supplement to them,
B. Liu (B) · H. Wang · D. Zhang
College of Pharmaceutical Engineering of Traditional Chinese Medicine,
Tianjin University of Traditional Chinese Medicine, Tianjin 301617, P. R. China
e-mail: liuboshi@tjutcm.edu.cn
© Springer Nature Singapore Pte Ltd. 2021
Y. Dong (ed.), Aptamers for Medical Applications,
https://doi.org/10.1007/978-981-33-4838-7_5
115
Aptamer-Based Medical Devices
Boshi Liu, Haixia Wang, and Di Zhang
Abstract Medical devices have undergone an evolution over thousands of years
with the intention to improve the health of people. Aptamers are single-stranded
nucleotides that can specifically bind to their targets. They are promising alternatives
of antibodies in the field of medical devices owing to the property of specific binding
to their targets, as well as the advantages such as easy synthesis and modification,
chemical stability, low immunogenicity, and competitive cost, etc. Nevertheless, to
our knowledge, there are no aptamer-based medical devices officially approved in
the market. Therefore, in this chapter, we first introduced the definition, history,
and market of medical devices. Then, some potentially prototypical aptamer-based
medical devices related clinical trials, patents, and papers were introduced from two
aspects according to their application in “diagnosis” and “therapies,” respectively.
Finally, we proposed our perspectives and insights for the development of aptamerbased medical devices.
Keywords Aptamers · Antibodies · Medical devices · Biomarkers · Diagnosis ·
Therapeutics
5.1 Introduction
Medical devices are healthcare products that do not achieve their purpose by chemical
action or by being metabolized [1]. The U. S. Food and Drug Administration (FDA)
defines a medical device as:
• “an instrument, apparatus, implement, machine, contrivance, implant, in vitro
reagent, or other similar or related article, including a component part or accessory
which is: recognized in the official National Formulary, or the United States
Pharmacopoeia, or any supplement to them,
B. Liu (B) · H. Wang · D. Zhang
College of Pharmaceutical Engineering of Traditional Chinese Medicine,
Tianjin University of Traditional Chinese Medicine, Tianjin 301617, P. R. China
e-mail: liuboshi@tjutcm.edu.cn
© Springer Nature Singapore Pte Ltd. 2021
Y. Dong (ed.), Aptamers for Medical Applications,
https://doi.org/10.1007/978-981-33-4838-7_5
115