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Biosensors
Volume 16
Issue 5
10.3390/bios16050297
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Review

Synthetic Biology-Enabled Biosensing Platforms for Point-of-Care In Vitro Diagnostics: Programmable Modules, Clinical Applications, and Translational Challenges

by
Changjie Bao
1,
Honglin Zhang
2,
Lin Jiang
1,
Tianhui Liu
1,
Wei Liu
1,
Qi Qi
1,
Xuejiao Ren
3,
Hongxun Fu
4,* and
Meiyan Sun
1,*
1
Academy of Laboratory, Jilin Medical University, Jilin 132013, China
2
College of Basic Medical Sciences, Jilin Medical University, Jilin 132013, China
3
School of Life Science, and Technology, Changchun University of Science and Technology, Changchun 130022, China
4
College of Biomedical Engineering, Jilin Medical University, Jilin 132013, China
*
Authors to whom correspondence should be addressed.
Biosensors 2026, 16(5), 297; https://doi.org/10.3390/bios16050297
Submission received: 14 April 2026 / Revised: 13 May 2026 / Accepted: 18 May 2026 / Published: 20 May 2026
(This article belongs to the Section Biosensors and Healthcare)
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Abstract

Synthetic biology is reshaping in vitro diagnostics (IVD) by enabling programmable and modular biosensing elements that can be integrated into point-of-care testing (POCT) platforms. Compared with conventional assays that depend on fixed chemistries and centralized instrumentation, synthetic biology-based systems offer adaptable molecular recognition, tunable signal processing, and flexible readout formats for decentralized diagnostics. In this review, we present synthetic biology-enabled IVD as programmable biosensing platforms organized into four functional layers: molecular recognition, signal transduction and amplification, output generation, and system integration. We discuss four major enabling modules, including cell-free protein synthesis (CFPS) systems, aptamer and riboswitch sensors, CRISPR-Cas diagnostic platforms, and microfluidic integration technologies. We summarize representative clinical applications from 2021 to 2025 in infectious disease detection, cancer biomarker analysis, and drug metabolism/toxicity screening. In addition, we examine practical considerations beyond analytical sensitivity, including matrix tolerance, workflow complexity, manufacturability, quantitative capability, and regulatory readiness. Finally, we highlight future directions for programmable diagnostics, including AI-assisted biosensor design, multimodal readouts, interoperable platform architectures, and real-world clinical validation.
Keywords: synthetic biology; biosensing platform; point-of-care testing; CRISPR-Cas; cell-free protein synthesis; microfluidics synthetic biology; biosensing platform; point-of-care testing; CRISPR-Cas; cell-free protein synthesis; microfluidics
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MDPI and ACS Style

Bao, C.; Zhang, H.; Jiang, L.; Liu, T.; Liu, W.; Qi, Q.; Ren, X.; Fu, H.; Sun, M. Synthetic Biology-Enabled Biosensing Platforms for Point-of-Care In Vitro Diagnostics: Programmable Modules, Clinical Applications, and Translational Challenges. Biosensors 2026, 16, 297. https://doi.org/10.3390/bios16050297

AMA Style

Bao C, Zhang H, Jiang L, Liu T, Liu W, Qi Q, Ren X, Fu H, Sun M. Synthetic Biology-Enabled Biosensing Platforms for Point-of-Care In Vitro Diagnostics: Programmable Modules, Clinical Applications, and Translational Challenges. Biosensors. 2026; 16(5):297. https://doi.org/10.3390/bios16050297

Chicago/Turabian Style

Bao, Changjie, Honglin Zhang, Lin Jiang, Tianhui Liu, Wei Liu, Qi Qi, Xuejiao Ren, Hongxun Fu, and Meiyan Sun. 2026. "Synthetic Biology-Enabled Biosensing Platforms for Point-of-Care In Vitro Diagnostics: Programmable Modules, Clinical Applications, and Translational Challenges" Biosensors 16, no. 5: 297. https://doi.org/10.3390/bios16050297

APA Style

Bao, C., Zhang, H., Jiang, L., Liu, T., Liu, W., Qi, Q., Ren, X., Fu, H., & Sun, M. (2026). Synthetic Biology-Enabled Biosensing Platforms for Point-of-Care In Vitro Diagnostics: Programmable Modules, Clinical Applications, and Translational Challenges. Biosensors, 16(5), 297. https://doi.org/10.3390/bios16050297

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