Safety tests and clinical research on buccal and nasal microneedle swabs for genomic analysis

JeongHyeon Kim; Jae-Woo Moon; Gyeong Ryeong Kim; Wonsub Kim; Hae-Jin Hu; Won-Jun Jo; Seung-Ki Baek; Gil-Hwan Sung; Jung Ho Park; Jung-Hwan Park

doi:10.3389/fbioe.2023.1296832

Safety tests and clinical research on buccal and nasal microneedle swabs for genomic analysis

Front Bioeng Biotechnol. 2023 Dec 5:11:1296832. doi: 10.3389/fbioe.2023.1296832. eCollection 2023.

Authors

Affiliations

¹ Department of Bionano Technology and Gachon BioNano Research Institute, Gachon University, Seongnam, Republic of Korea.
² Endomics Inc, Seongnam, Republic of Korea.
³ QuadMedicine R&D Centre, QuadMedicine Co. Ltd., Seongnam, Republic of Korea.
⁴ Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.

Abstract

Conventional swabs have been used as a non-invasive method to obtain samples for DNA analysis from the buccal and the nasal mucosa. However, swabs may not always collect pure enough genetic material. In this study, buccal and nasal microneedle swab is developed to improve the accuracy and reliability of genomic analysis. A cytotoxicity test, a skin sensitivity test, and a skin irritation test are conducted with microneedle swabs. Polymer microneedle swabs meet the safety requirements for clinical research and commercial use. When buccal and nasal microneedle swabs are used, the amount of genetic material obtained is greater than that from commercially available swabs, and DNA purity is also high. The comparatively short microneedle swab (250 μm long) cause almost no pain to all 25 participants. All participants also report that the microneedle swabs are very easy to use. When genotypes are compared at five SNP loci from blood of a participant and from that person's buccal or nasal microneedle swab, the buccal and nasal microneedle swabs show 100% concordance for all five SNP genotypes. Microneedle swabs can be effectively used for genomic analysis and prevention through genomic analysis, so the utilization of microneedle swabs is expected to be high.

Keywords: buccal microneedle swab; clinical research; genomic analysis; nasal microneedle swab; safety test.

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This work was supported by the Gachon University research fund of 2021 (GCU-202110370001) and supported by the Technology development Program(S2956928) funded by the Ministry of SMEs and Startups (MSS, Korea).