Diagnostic biomarkers based on epigenetic changes such as DNA methylation are promising tools for early cancer diagnosis. However, there are significant difficulties in directly and specifically detecting methylated DNA regions. Here, we report an electrochemical sensing system based on magnetic nanoparticles that enable a quantitative and selective analysis of the methylated septin9 (mSEPT9) gene, which is considered a diagnostic marker in early stage colorectal cancer (CRC). Methylation levels of SEPT9 in CRC samples were successfully followed by the selective recognition ability of a related peptide nucleic acid (PNA) after hybridization with DNA fragments in human patients’ serums and plasma (n = 10). Moreover, this system was also adapted into a point-of-care (POC) device for a one-step detection platform. The detection of mSEPT9 demonstrated a limit of detection (LOD) value of 0.37% and interference-free measurement in the presence of branched-chain amino acid transaminase 1 (BCAT1) and SRY box transcription factor 21 antisense divergent transcript 1 (SOX21-AS1). The currently proposed functional platform has substantial prospects in translational applications of early CRC detection.

The evolution of biosensors and diagnostic devices has been thriving in its ability to provide reliable tools with simplified operation steps. These evolutions have paved the way for further advances in sensing materials, strategies, and device structures. Polymeric composite materials can be formed into nanostructures and networks of different types, including hydrogels, vesicles, dendrimers, molecularly imprinted polymers (MIP), etc. Due to their biocompatibility, flexibility, and low prices, they are promising tools for future lab-on-chip devices as both manufacturing materials and immobilization surfaces. Polymers can also allow the construction of scaffold materials and 3D structures that further elevate the sensing capabilities of traditional 2D biosensors. This review discusses the latest developments in nano-scaled materials and synthesis techniques for polymer structures and their integration into sensing applications by highlighting their various structural advantages in producing highly sensitive tools that rival bench-top instruments. The developments in material design open a new door for decentralized medicine and public protection that allows effective onsite and point-of-care diagnostics.

The growing demand for personalized treatments and the constant observation of vital signs for extended periods could positively solve the problematic concerns associated with the necessity for patient control and hospitalization. The impressive development in biosensing devices has led to the creation of man-made implantable devices that are temporarily or permanently introduced into the human body, and thus, diminishing the pain and discomfort of the person. Despite all promising achievements in this field, there are some critical challenges to preserve reliable functionality in the complex environment of the human body over time. Biosensors in the in vivo environment are required to have specific features, including biocompatibility (minimal immune response or biofouling), biodegradability, reliability, high accuracy, and miniaturization (flexible, stretchable, lightweight, and ultra-thin). However, the performance of implantable biosensors is limited by body responses and insufficient power supplies (due to minimized batteries/electronics and data transmission without wires). In addition, the current processes and developments in the implantable biosensors field will open new routes in biomedicine and diagnostic systems that monitor occurrences happening inside the body in a certain period. This topical paper aims to give an overview of the state-of-the-art implantable biosensors and their design methods. It also discusses the latest developments in material science, including nanomaterials, hydrogel, hydrophilic, biomimetic, and other polymeric materials to overcome failures in implantable biosensors’ reliability. Lastly, we discuss the main challenges faced and future research prospects toward the development of dependable implantable biosensors.