AUTHOR=Cai Songhua , Deng Youjun , Wang Zhe , Zhu Junyu , Huang Chujian , Du Longde , Wang Chunguang , Yu Xiangyang , Liu Wenyi , Yang Chenglin , Wang Zhe , Wang Lixu , Ma Kai , Huang Rui , Zhou Xiaoyu , Zou Heng , Zhang Wenchong , Huang Yan , Li Zhi , Qin Tiaoping , Xu Tao , Guo Xiaotong , Yu Zhentao TITLE=Development and clinical validation of a microfluidic-based platform for CTC enrichment and downstream molecular analysis JOURNAL=Frontiers in Oncology VOLUME=Volume 13 - 2023 YEAR=2023 URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1238332 DOI=10.3389/fonc.2023.1238332 ISSN=2234-943X ABSTRACT=Background: Although many CTC isolation and detection methods can provide information on cancer cell counts, downstream gene and protein analyses remain incomplete. Therefore, it is crucial to develop a technology that can provide comprehensive information on both the number and profile of CTC. Methods: In this study, we developed a novel microfluidics-based CTC separation and enrichment platform that provided detailed information about CTC. Results: This platform exhibits exceptional functionality, achieving high rates of CTC recovery (>85%) and purification (∼ 10 4 enrichment), as well as accurate detection (95.98%), providing intact and viable CTC for downstream This is a provisional file, not the final typeset article analysis. This platform enables successful separation and enrichment of CTC from a 4 mL wholeblood sample within 15 minutes. Additionally, CTC subtypes, selected protein expression levels on the CTC surface, and target mutations in selected genes can be directly analyzed for clinical utility using immunofluorescence and real-time polymerase chain reaction, and the detected PD-L1 expression in CTC is consistent with immunohistochemical assay results. Conclusion: The microfluidics-based CTC enrichment platform and downstream molecular analysis together provide a possible alternative to tissue biopsy for precision cancer management, especially for patients whose tissue biopsies are unavailable.