Rapid and accurate detection of biomolecular targets is essential for early disease diagnosis, effective patient management, and public health surveillance. Conventional laboratory-based diagnostic techniques such as PCR, ELISA, and sequencing, although highly sensitive, are time-consuming, require sophisticated instrumentation, trained personnel, and centralized laboratory facilities. These limitations restrict their use in point-of-care settings, resource-limited environments, and situations requiring rapid decision-making. To address these challenges, we have developed an innovative Portable Multiplex Biosensor for Rapid Disease Screening and Molecular Diagnostics, designed to enable sensitive, specific, and simultaneous detection of multiple biomolecular targets in a compact, user-friendly format.
This project focuses on the development of a novel biosensing platform based on advanced electrochemical detection principles integrating FT Voltammetry technology with multiplex capability. The biosensor is engineered to detect RNA, DNA, and protein biomarkers within a single platform, thereby expanding its application across infectious diseases, cancer diagnostics, genetic screening, and personalized medicine. The multiplexing capability significantly reduces time, cost, and sample volume while enhancing diagnostic efficiency.
The device comprises three major components: (1) a disposable biosensing cartridge containing functionalized electrodes, (2) a portable electronic reader unit incorporating signal acquisition and processing modules, and (3) integrated software for data interpretation and display. The sensing surface is modified with selective biorecognition elements such as oligonucleotide probes, antibodies, or aptamers, enabling highly specific interaction with target analytes. Upon binding of target molecules, electrochemical signals are generated and captured through FT Voltammetry, providing high sensitivity with low background noise.
One of the key innovations of this project is the multiplex detection capability, allowing simultaneous identification of multiple biomarkers within a single assay. This is particularly beneficial for syndromic testing, where several pathogens or biomarkers need to be evaluated concurrently. For example, the device can be adapted for respiratory pathogen panels, cancer biomarker profiling, metabolic disease screening, or genetic testing. The modular design of the biosensor enables easy customization depending on clinical requirements.
To demonstrate the practical applicability of the device, one of the projects under this platform focuses on the detection of Human Papilloma Virus (HPV), particularly the HPV-16 E7 oncogene sequence associated with cervical cancer development. HPV predominantly affects the genital region including the cervix, vagina, penis, vulva, scrotum, rectum, and anus. Among more than 100 HPV types, at least 14 are considered high-risk for cancer, with HPV-16 being one of the most significant contributors. Early identification of HPV-16 E7 gene sequences plays a crucial role in preventing cancer progression through timely intervention.
In this study, the targeted HPV-16 E7 sequence was detected using a sandwich hybridization strategy on a carbodiimidazole-modified interdigitated electrode (IDE) sensing surface. The capture probe was immobilized on the IDE surface, allowing hybridization with the target HPV-16 E7 DNA sequence. Subsequently, a reporter sequence was introduced to form a capture-target-reporter sandwich complex. Detection performance was evaluated using reporter sequences both in the presence and absence of gold nanorods (GNR). The target sequence at femtomolar levels successfully paired with the immobilized capture probe, and detection sensitivity reached as low as 1 attomolar. The incorporation of gold nanorods significantly enhanced the electrochemical signal, resulting in approximately 1000-fold current enhancement compared to conditions without reporter sequences. This highly sensitive sandwich detection strategy demonstrates the capability of the biosensor to identify HPV-16 associated cervical cancer risk at extremely low concentrations, highlighting its suitability for early screening and preventive diagnostics.
The developed system emphasizes portability and ease of use. The handheld reader operates with low power consumption and can be used in remote or resource-limited settings. The user interface is designed to provide rapid readouts, and the device can be integrated with mobile applications for data storage, analysis, and telemedicine applications. This connectivity supports real-time reporting and epidemiological monitoring.
Preliminary validation of the biosensor has been successfully performed at the laboratory level using in-vitro samples. The results demonstrated high sensitivity, reproducibility, and specificity for selected molecular targets including nucleic acids and proteins. The multiplex platform maintained consistent performance across multiple channels, confirming the feasibility of simultaneous multi-analyte detection.
The proposed biosensor offers several advantages over conventional diagnostic approaches:
- Rapid detection with minimal sample preparation
- Multiplex capability for simultaneous biomarker analysis
- High sensitivity and specificity
- Portable and user-friendly design
- Cost-effective compared to laboratory-based methods
- Potential for point-of-care and field deployment
- Scalability for different disease panels
- Compatibility with digital health and telemedicine platforms
This innovation has significant potential impact across multiple sectors. In healthcare, it can facilitate early diagnosis, improve treatment outcomes, and reduce healthcare costs. In public health, it enables rapid screening during outbreaks and supports surveillance programs. In cancer prevention, such as HPV-associated cervical cancer, the device enables early detection of oncogenic sequences before clinical manifestation. In research, it provides a versatile platform for biomarker discovery and validation. The device can also be utilized in environmental monitoring and food safety testing with appropriate modifications.
From a commercialization perspective, the biosensor platform has strong market potential due to the growing demand for point-of-care diagnostics and personalized medicine solutions. The modular architecture allows development of disease-specific cartridges, creating opportunities for scalable production and commercialization. The compact design, combined with multiplex capability, positions this innovation competitively within the diagnostic technology landscape.
Currently, the project has reached laboratory validation stage with proof-of-concept demonstrated using in-vitro samples including HPV detection. Future work will focus on clinical validation, optimization of multiplex panels, device miniaturization, integration with digital platforms, and regulatory pathway development. Collaborations with clinical partners and industry stakeholders are planned to facilitate translation from prototype to deployable product.
In conclusion, the Portable Multiplex Biosensor for Rapid Disease Screening and Molecular Diagnostics represents an innovative, practical, and scalable solution to address current limitations in diagnostic testing. By combining portability, multiplex capability, and ultra-sensitive detection within a single platform, this technology has the potential to transform disease screening and molecular diagnostics, particularly in point-of-care and resource-limited settings, while also supporting early cancer detection such as HPV-associated cervical malignancies.
