An important unmet need
Excellent care for people with suspected infections involves rapid diagnosis and treatment. For instance, administering the correct antibiotic as soon as possible to patients with blood infections dramatically improves their chances of survival. On the other hand, using antibiotics when they do not benefit patients exposes them unnecessarily to side effects and potential antibiotic resistance. Despite all the advances in medicine, we still do not have the technology available that can quickly diagnose what kind of infection a patient has and what treatment they need. Even the best of the currently available diagnostic methods are too slow to help clinicians.
The RAPP-ID project aimed to provide an integrated solution that addresses the technological challenges to enhance clinical decision-making and improve the quality of care and clinical outcomes for patients. More specifically, it aimed to develop rapid point-of-care platforms (POCTs) for the rapid detection of bacteria, tuberculosis bacteria, fungi, and viruses as well as patients’ markers of infection (less than 2 hours in hospitals, and less than 30 min in primary care).
Good outcomes in spite of challenges
Developing diagnostic tests for infectious diseases is very challenging, and due to limited time and resources, the project fell short of developing fully-fledged rapid diagnostic tests. However, some of the innovations and technologies developed within the project could speed up the development of such tests in the future. Furthermore, the project produced other resources and tools which could be useful for the future development of POCTs.
Defining user requirements
Many tests have been produced in the past that are miracles of bioengineering but have not provided clinicians with what they require for optimal care. In order to understand the requirements for these tests, the RAPP-ID team put a lot of effort into drawing up user specifications which outline what diagnostic tests for different infectious diseases should even look like. These guidelines could help anyone working on diagnostic tests for infectious diseases in the future.
Prototype of the breath sampler
After the user specifications were defined, the project team set out to develop some of the technologies needed to create rapid diagnostic tests. Perhaps the biggest and most innovative achievement of the project was the development of a prototype breath sampler for influenza. Patients exhale into the instrument, which captures tiny particles in their breath, and then uses that sample to detect the presence of pathogens. During the project, the team was able to demonstrate that the instrument is able to capture airborne pathogens, and started testing it on patients in the clinic. However, the technology is still in the relatively early stages of development, and would need more time and resources to be developed into a clinically validated test. This innovation is now part of IMI2 – Call 11 on the sustainability of IMI project results and might be developed further by one of the winning consortia.
Chips for diagnosing pneumonia
Another important project achievement was the prototype of the ventilator-associated pneumonia (VAP) test. VAP is a very serious infection in people who are in intensive care. The illness has a very high death rate and diagnostic tests that could detect these bacteria quickly are urgently needed. The RAPP-ID project developed chips which help isolate the DNA of these bacteria from aspirates of VAP patients. As the amount of DNA which can be extracted from these bacteria is very low, the DNA from these samples had to be amplified before detection. The chip was aimed to run on an instrument making it a complete diagnostic test. Although nearly there, this device-chip combination would require a further software update to run autonomously – a process which could not be fully completed within the scope of the RAPP-ID project.
In addition to the innovations mentioned above, the project developed many other resources and innovations which are now available for future research, including a technology for the acoustic manipulation of bacteria with the help of beads, and cell lines for various bacterial strains.
For the benefit of industry and academia
The academic community benefited from the project in several ways. First of all, they made big progress in developing some of their ideas for rapid diagnostic tests. Secondly, by interacting with other academic partners and industry, they were able to expand those ideas and add certain components to their technology platforms which they could not have developed on their own. The project also resulted in about 30 scientific publications, with more to come.
Thanks to RAPP-ID, both the pharmaceutical industry and academic partners learned about the challenges involved in developing diagnostic tests and bringing them to the market. As the first IMI project of this kind, RAPP-ID was in many ways a learning experience for everyone involved and could help enhance collaboration between the medicine and diagnostic worlds, shaping better EU-funded diagnostic projects in the future.
All of the partners in the project, including academia, industry and SMEs, also benefitted from the collaboration and new partnerships formed within the project. Some of these collaborations are continuing and have resulted in new spin out projects.
The findings of the RAPP-ID project inspired at least two spin out projects funded by the EU. The first focused on urinary tract infections (UTIs) and developed a chip which can detect drug-resistant, UTI-causing bacteria. The chip is similar to the one developed in RAPP-ID for VAP.
The second spin out project, New diagnostics for infectious diseases (ND4ID), is a Marie Skłodowska -Curie project which will enable 15 PhD students to conduct their research at industry and academic laboratories across Europe. It will run until early 2020 and involves many of the RAPP-ID project partners.