A review in ACS Nano examines the phases of development of a diagnostic device, highlighting the critical aspects and limitations that slow down the process of bringing an innovative technology from the laboratory to the marketplace. This work was conducted by members of the Nanobioelectronics and Biosensors Group at the BIST centre ICN2.
The outbreak of the COVID-19 pandemic in early 2020 and its rapid spread led teams of researchers around the world to put their efforts into developing new technologies that would allow rapid and reliable diagnosis of the disease and testing of large numbers of individuals. Various innovative solutions, some based on nanomaterials and nanotechnologies, have been proposed. Nevertheless, we currently still rely on well-established diagnostic techniques. This is due to the long process a new technology has to go through in order to be developed, validated, licensed, transferred to the industry, and scaled up to be brought to market.
In a paper published in ACS Nano, researchers from the ICN2 Nanobioelectronics and Biosensors Group (NB2) –led by ICREA Prof Arben Merkoçi— use the diagnostics of COVID-19 as a model to describe the various stages in the development of a diagnostic device, from its conception to the introduction onto the market, and the critical aspects and difficulties that can slow down this process. First authors of the review are Dr Giulio Rosati— postdoctoral researcher in the NB2 group— Dr Andrea Idili and Dr Claudio Parolo –former members of the same group. Researchers of the Université Paris-Saclay (France), Asphalion (Barcelona, Spain) and IBM Research (Zurich, Switzerland) also participated in this work.
After a discussion on the biomarkers used for detecting a viral infection from biological fluids, the authors provide an overview of the current technologies and devices used to diagnose COVID19, at various stages of the disease and with different levels of reliability, and give an idea of the great advantages that nanomaterials and nanotechnologies can bring in this context. They then analyse the steps that take a new technology from research in the laboratory to market and, therefore, to clinical practice, focusing on highlighting the bottlenecks along the process —with the greatest difficulties being encountered in the transition from the lab setting to the real clinical conditions and in the adaptation of production processes to large quantities and short timescales.
Finally, the authors provide some ideas to possibly improve and speed up this process, such as giving more financial support and recognition in high-impact journals to research teams that make the effort to push their technologies towards industrialisation and commercialisation, and establishing international biobanks of biological samples (which could also provide access to high biosafety-level laboratories) to facilitate and accelerate the clinical trials step.
Learn more on the ICN2 website.