Development of a Digital Optical Biosensor for Point-of-Care Assessment of CAR T-Cell Therapies

Chimeric Antigen Receptor (CAR) T-cell therapy has emerged as a promising treatment for certain cancers, but its clinical success is often hindered by the risk of Cytokine Release Syndrome (CRS) — a severe immune response triggered by elevated cytokine levels. Early detection of CRS is critical for effective intervention and patient safety. To address this challenge, this study unveils the development of a digital optical biosensor integrated into a microfluidic chip for real-time, point-of-care monitoring of CAR T-cell therapy. The biosensor is designed to simultaneously quantify CAR T cells and detect key cytokines, such as Interleukin (IL)-6 and Interferon (IFN)-γ, directly from patient blood samples. Functionalized with specific molecular probes, the microfluidic chip enables highly selective biomarker detection through automated optical imaging, ensuring rapid and accurate results. The system’s performance was assessed based on sensitivity, dynamic range, and response time, benchmarking it against gold-standard methods like Enzyme Linked Immunosorbent Assay (ELISA). Results demonstrated a significant reduction in assay time while maintaining high detection efficiency, positioning this biosensor as a strong candidate for point-of-care applications.
By offering a portable, cost-effective, and real-time diagnostic solution, this biosensor has the potential to revolutionize patient monitoring in immunotherapy. Its seamless integration into clinical workflows could enhance clinical decision-making, improve patient outcomes, and lower healthcare costs. Beyond CAR T-cell therapy, this technology sets the foundation for broader applications in personalized medicine, advancing biosensing solutions for precise and accessible healthcare.