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Platform for ultra-sensitive Point-of-Care diagnostics for Infectious Diseases

Periodic Reporting for period 1 - PoC-ID (Platform for ultra-sensitive Point-of-Care diagnostics for Infectious Diseases)

Reporting period: 2015-05-01 to 2016-10-31

The aim of the PoC-ID project is to develop new micro- and nanoelectronic-based sensing and integration concepts for advanced miniaturised in vitro diagnostic devices. The project addresses the increasing demand for rapid and ultra-sensitive point-of-care diagnostics to reduce healthcare costs and increase the quality of life with a focus on infectious diseases, one of the world’s leading causes of morbidity and death.
Interdisciplinary collaboration using the technology and expertise of the consortium members will be applied to develop and test a breakthrough PoC prototype for the diagnosis of respiratory syncytial virus infections and host responses in the paediatric context. PoC-ID will enable new types of point-of-care diagnostics for virtually any type of complex liquid sample.
Applications are disease diagnosis, monitoring of therapeutic responses, clinical research of pathogen-host interaction and personalised medicine. The platform technology can easily be adapted to a variety of diagnostic or bio-sensing purposes, such as in health/environmental monitoring or food quality testing. PoC-ID will combine the detection of both pathogens and host responses leading to more accurate diagnosis as compared to the current standard, which is focused on detection of pathogens only. This novel approach will support prevention and control of pathogen spread and enable faster and more personalised patient treatment.
Improved performance in terms of robustness, sensitivity and selectivity will be reached by a combination of innovative nano-membrane technology, molecular engineered capture molecules and two novel sensing concepts. Further advances will be realised in terms of usability and speed of data-analysis arising from the integration of sensors, read-out electronics and microfluidics into one user-friendly point-of-care (PoC) platform. Costs of the new disposable sensors will be ultra-low at high volumes, thanks to designing into microelectronics production flows.
The objectives of the PoC-ID project are:
Objective 1: Development of novel micro- and nanoelectronic-based bio-sensors
Two independent sensor concepts will be developed, increasing device-flexibility and reducing risk. Both concepts work label-free (no expensive biological active buffers or enzymes required for detection) and have a high potential towards robustness, high sensitivity, as well as rapid and multiplexed detection due to parallel electric readout.
Oj 1.1 - Development of a graphene-based Field-Effect Transistor sensor (BioGrFET)
Oj 1.2 - Development of a capacitive BioMEMS sensor
Objective 2: Development of new functionalisation tools for improved selectivity and sensitivity
Oj 2.1 - Molecular engineering of sensing-adapted biomimetic recognition molecules
Oj 2.2 - Development of functionalisation strategies and novel functionalisation nanointerposer
Objective 3: Multiplexed measurement of host-response biomarkers and pathogen
Oj 3.1 - Identification & implementation of multiple targets for more reliable pathogen detection
Oj 3.2 - Multiplexing of sensor dyes for parallelised detection
Objective 4: Integration of detection technologies into a device for point-of-care diagnostics
Oj 4.1 - Development of a microfluidic system and novel microfluidic fabrication possibilities compatible to functionalised bio-sensors
Oj 4.2 - Hybrid microelectronic-microfluidic packaging for a disposable sensing unit, producible for mass-manufacturing
Oj 4.3 - System integration of disposable sensor unit interface, readout-electronic and user-interface in a handheld device for point-of-care application
Objective 5: Impact maximising activities and preclinical testing of the developed point-of-care diagnostic device for the use-case of respiratory viral infection
Oj 5.1 - Preclinical testing of the prototype for respiratory virus detection
Oj 5.2 - Impact maximising activities; An exploitation plan will be developed for the overall system and potential spin-off results, c
After the first half, the PoC-ID project is well on target. The grounds for the technical and scientific work have been laid. All contracts are signed, Ethical approval has been obtained, the Advisory Board (EEAB) has been established, internal webspace and website are online and communication between interdisciplinary partners has emerged in an effective and efficient manner. Following several discussions, the targets to be detected by the sensors have been defined. Sequences of host biomarkers and viral proteins were selected for in vitro selection of new capture molecules. Besides the target molecules, the overall system requirements from user’s perspective were specified and collated into a specification document. The focus for the first 18 months of technical development was on device design and process development aiming for proof-of-concept prototypes (sensor development) and flexible technology toolboxes (packaging and device design). The sensors showed first good results in artificial environments and targets, but need to prove usability for the targeted application until month 20. The early development of protocols for sample collection and storage will enable sufficient sample availability for the sensor evaluation phase. The first important step towards functionalisation has been achieved – chemistry for immobilisation of capture molecules to the sensors had been developed and proved to be working. The exit of the partner Noxxon in month 20 is planned to be compensated by a new partner soon. Even if not, Noxxon already achieved the minimum requirement of two functional capture molecules for RSV-detection.
The immobilisation chemistry, sensor concepts and first biosensor-packaging concepts have been developed beyond the previous state of the art and the respective IP landscape is currently under investigation for potential patent filing.
The expected potential impact stays as relevant as at the beginning of the project: The high selectivity of biomarker detection facilitates application for personalized medicine and the rapid measurement provides the opportunity of bedside patient monitoring. Increased sensitivity and reliability as well as rapid detection will enable earlier disease diagnosis, which will reduce the length of stay in a hospital. Once successfully implemented, the PoC-ID platform will lead to (1) strong improvement in patient care, (2) earlier recovery of patients, (3) significant cost reduction for the healthcare system, (4) accelerated development towards personalized medicine and (5) new market opportunities for SMEs, which will benefit the EU economy.