Periodic Reporting for period 1 - EDISENS (An Edible Microelectrofluidic Biosensor for Gastric Enzyme Quantification)
Reporting period: 2024-01-01 to 2025-12-31
EDISENS aims at delivering edible biosesnors measuring specific biomarkers in the gastrointestinal (GI) tract for early detection of GI disorders. This is achieved by integrating microfluidics, electronics, and bioreagents into an edible device that can be digested by the human body after completing its task.
Nowadays, commercial ingestible devices for GI tract monitoring are well-established and represent an exponentially growing business, expected to reach $1495 billion by 2027. However, these minimally invasive systems typically use non-degradable materials encapsulated into a biocompatible matrix and require hospitalisation to be administrated. Due to their non-degradable nature, they suffer from retention risk within the GI tract. Damage to the encapsulant can also cause the release of potentially toxic material within the human body causing further complications. Furthermore, the disposal of these non-degradable devices poses issues as they are potentially biohazard waste and contribute to the accumulation of electronic waste (e-waste) in wastewater and the environment. These concerns about invasivity, toxicity, possible complications, and environmental impact of ingestible devices call for an immediate shift of paradigm toward the use of novel materials.
Edible devices represent the next generation of ingestible technology as they use safe-to-eat bioresorbable materials, overcoming any concern about toxicity. Edible devices are designed to be digested by the human body; as such, there is no associated retention risk, and they eliminate costs and issues associated with their disposal. EDISENS aims at integrating microfluidics, electronics, and biomolecules into an edible biosensor, an unprecedented device in the scientific literature, and employ the novel device as a tool for non-invasive access to gastric fluid testing.
The ultimate aim of this action is to deliver and demonstrate an edible biosensor for gastric biomarkers and quantify its key performance metrics - including limit of detection, sensitivity and specificity - in-vitro with simulated gastric fluid.
Nowadays, commercial ingestible devices for GI tract monitoring are well-established and represent an exponentially growing business, expected to reach $1495 billion by 2027. However, these minimally invasive systems typically use non-degradable materials encapsulated into a biocompatible matrix and require hospitalisation to be administrated. Due to their non-degradable nature, they suffer from retention risk within the GI tract. Damage to the encapsulant can also cause the release of potentially toxic material within the human body causing further complications. Furthermore, the disposal of these non-degradable devices poses issues as they are potentially biohazard waste and contribute to the accumulation of electronic waste (e-waste) in wastewater and the environment. These concerns about invasivity, toxicity, possible complications, and environmental impact of ingestible devices call for an immediate shift of paradigm toward the use of novel materials.
Edible devices represent the next generation of ingestible technology as they use safe-to-eat bioresorbable materials, overcoming any concern about toxicity. Edible devices are designed to be digested by the human body; as such, there is no associated retention risk, and they eliminate costs and issues associated with their disposal. EDISENS aims at integrating microfluidics, electronics, and biomolecules into an edible biosensor, an unprecedented device in the scientific literature, and employ the novel device as a tool for non-invasive access to gastric fluid testing.
The ultimate aim of this action is to deliver and demonstrate an edible biosensor for gastric biomarkers and quantify its key performance metrics - including limit of detection, sensitivity and specificity - in-vitro with simulated gastric fluid.
Activities. The main activities performed during the EDISENS project are summarised below:
1) Design, fabrication, and testing of edible passive microfluidics. Edible passive microfluidic platforms were developed to confine liquid samples under test. Fourteen candidate edible material formulations for passive fluidic channels were experimentally evaluated. Their wettability properties were systematically characterised, and their suitability for mould-based microfabrication was assessed. Passive microfluidic structures, including single channels and reaction chambers, were fabricated, tested, and compared. As a result, a novel protocol for the fabrication of fully edible passive microfluidic channels was established.
2) Development of an edible transducer. In collaboration with members of the research group, an extended-gate electrolyte-gated field-effect transistor (EGOFET) was designed, fabricated, and tested using exclusively edible materials. The device employed a toothpaste pigment as the semiconductor. Key electronic performance metrics of the fabricated devices were experimentally quantified.
3) Identification of an edible biorecognition layer for H2O2 biosensing. Candidate edible redox systems for H2O2 detection were experimentally screened. A specific edible redox system was selected and characterised using UV–Vis absorption spectroscopy and electrochemical techniques.
4) Biosensor development. The selected biorecognition layer was integrated into the EGOFET architecture, resulting in a fully edible biosensor. The device was validated for H2O2 quantification, an important reactive oxygen species associated with gastrointestinal inflammation, via a controlled redox reaction.
5) Biosensor testing under physiologically relevant conditions. H2O2 biosensing performance was evaluated under various in vitro physiologically relevant conditions, including different temperatures, pH values, and the presence of potentially interfering agents. Device responsivity was consistently confirmed across all tested conditions.
6) Biosensor functional modification. The biosensor was successfully adapted to detect glucose, cholesterol, and gastric peroxidase through minimal modifications of the biorecognition layer.
7) Collaborative projects and knowledge transfer. Eight additional collaborative research projects were completed, all focused on sustainable and degradable electronic materials, resulting in published outcomes and direct collaboration with peer researcher fostering two-way knowledge transfer.
Main result. The main result of the project is the development and testing of an edible H2O2 biosensor, designed to be safely ingested and metabolized after use. The biosensor is validated for H2O2 quantification, a key reactive oxygen species associated with GI inflammations, via a controlled edible redox reaction. The device is tested in vitro and detects H2O2 in the 0–3 mM range, with a limit of detection of ~143.7 µM and sensitivity of 2.7 µC mM-1. As a proof-of-application, we demonstrate the use of the edible biosensor to detect metabolites (glucose and cholesterol) and enzymes (gastric peroxide activity) by minimal modifications of the biorecognition elements, and we validate the sensing mechanism in simulated physiological environment.
1) Design, fabrication, and testing of edible passive microfluidics. Edible passive microfluidic platforms were developed to confine liquid samples under test. Fourteen candidate edible material formulations for passive fluidic channels were experimentally evaluated. Their wettability properties were systematically characterised, and their suitability for mould-based microfabrication was assessed. Passive microfluidic structures, including single channels and reaction chambers, were fabricated, tested, and compared. As a result, a novel protocol for the fabrication of fully edible passive microfluidic channels was established.
2) Development of an edible transducer. In collaboration with members of the research group, an extended-gate electrolyte-gated field-effect transistor (EGOFET) was designed, fabricated, and tested using exclusively edible materials. The device employed a toothpaste pigment as the semiconductor. Key electronic performance metrics of the fabricated devices were experimentally quantified.
3) Identification of an edible biorecognition layer for H2O2 biosensing. Candidate edible redox systems for H2O2 detection were experimentally screened. A specific edible redox system was selected and characterised using UV–Vis absorption spectroscopy and electrochemical techniques.
4) Biosensor development. The selected biorecognition layer was integrated into the EGOFET architecture, resulting in a fully edible biosensor. The device was validated for H2O2 quantification, an important reactive oxygen species associated with gastrointestinal inflammation, via a controlled redox reaction.
5) Biosensor testing under physiologically relevant conditions. H2O2 biosensing performance was evaluated under various in vitro physiologically relevant conditions, including different temperatures, pH values, and the presence of potentially interfering agents. Device responsivity was consistently confirmed across all tested conditions.
6) Biosensor functional modification. The biosensor was successfully adapted to detect glucose, cholesterol, and gastric peroxidase through minimal modifications of the biorecognition layer.
7) Collaborative projects and knowledge transfer. Eight additional collaborative research projects were completed, all focused on sustainable and degradable electronic materials, resulting in published outcomes and direct collaboration with peer researcher fostering two-way knowledge transfer.
Main result. The main result of the project is the development and testing of an edible H2O2 biosensor, designed to be safely ingested and metabolized after use. The biosensor is validated for H2O2 quantification, a key reactive oxygen species associated with GI inflammations, via a controlled edible redox reaction. The device is tested in vitro and detects H2O2 in the 0–3 mM range, with a limit of detection of ~143.7 µM and sensitivity of 2.7 µC mM-1. As a proof-of-application, we demonstrate the use of the edible biosensor to detect metabolites (glucose and cholesterol) and enzymes (gastric peroxide activity) by minimal modifications of the biorecognition elements, and we validate the sensing mechanism in simulated physiological environment.
The vision of this action is to make clinical testing as easy as eating candy someday, and we believe that the demonstrated edible biosensor is a first step towards direct in vivo biosensing for the GI tract, which is safe, accessible at the point-of-care and sustainable.
The biosensor developed within EDISENS represents the first demonstration of a fully edible active biosensor based on enzymatic biorecognition and edible materials with electronic functionality. This prototype will enable a new class of safe, fully digestible biosensors for gastrointestinal monitoring, supporting home and point-of-care testing without the need for hospitalisation. By reducing risks associated with device retention and invasiveness, it streamlines clinical pathways and improves patient access to gastric fluid analysis. The approach delivers strong economic and environmental benefits by lowering healthcare costs and reducing medical and electronic waste through biodegradable device design.
The technology demonstrated within EDISENS, along with the associated collaborative projects, is highly versatile and has the potential to drive innovation in sustainable and degradable electronics. The use of edible electronic components in lieu of non-degradable ones has the potential to massively reduce e-waste, especially in single-use systems, regardless of their application. Edible devices can also benefit from infrastructures already implemented in the food industry for manufacturing, storage, and transport.
EDISENS advanced the current state of the art by i) delivering a new class of edible passive microfluidic devices (manuscript in preparation), ii) delivering a novel edible active biosensor for metabolites and biomarkers that can be digested by the body (manuscript under revision), iii) demonstrating the use of edible materials with electronic properties, such as for instance activated carbon as a conductor, to develop functional inks, sensors (temperature, umidity), digital circtuis, and power sources (published as collaborative projects).
The biosensor developed within EDISENS represents the first demonstration of a fully edible active biosensor based on enzymatic biorecognition and edible materials with electronic functionality. This prototype will enable a new class of safe, fully digestible biosensors for gastrointestinal monitoring, supporting home and point-of-care testing without the need for hospitalisation. By reducing risks associated with device retention and invasiveness, it streamlines clinical pathways and improves patient access to gastric fluid analysis. The approach delivers strong economic and environmental benefits by lowering healthcare costs and reducing medical and electronic waste through biodegradable device design.
The technology demonstrated within EDISENS, along with the associated collaborative projects, is highly versatile and has the potential to drive innovation in sustainable and degradable electronics. The use of edible electronic components in lieu of non-degradable ones has the potential to massively reduce e-waste, especially in single-use systems, regardless of their application. Edible devices can also benefit from infrastructures already implemented in the food industry for manufacturing, storage, and transport.
EDISENS advanced the current state of the art by i) delivering a new class of edible passive microfluidic devices (manuscript in preparation), ii) delivering a novel edible active biosensor for metabolites and biomarkers that can be digested by the body (manuscript under revision), iii) demonstrating the use of edible materials with electronic properties, such as for instance activated carbon as a conductor, to develop functional inks, sensors (temperature, umidity), digital circtuis, and power sources (published as collaborative projects).