COVID-19 diagnostics: what does it take for a new technology to move from concept to actual clinical practice?

by Virginia Greco

A review in "ACS Nano" examines the phases of the 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 ICN2 Nanobioelectronics and Biosensors Group.

The outbreak of the COVID-19 pandemic in early 2020 and its rapid spread led several teams of researchers worldwide to put their efforts in developing new technologies that would allow rapid and reliable diagnosis of the disease and testing of large numbers of individuals. Various innovative solutions, a few of which based on nanomaterials and nanotechnologies, have been proposed; nevertheless, currently we 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. Then, they 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 industrialization 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.

Image by Jordi Selma Barberá

Reference article:

Giulio Rosati, Andrea Idili, Claudio Parolo, Celia Fuentes-Chust, Enric Calucho, Liming Hu, Cecilia de Carvalho Castro e Silva, Lourdes Rivas, Emily P. Nguyen, José F. Bergua, Ruslan Alvárez-Diduk, José Muñoz, Christophe Junot, Oriol Penon, Dominique Monferrer, Emmanuel Delamarche, and Arben Merkoçi, Nanodiagnostics to Face SARS-CoV-2 and Future Pandemics: From an Idea to the Market and Beyond. ACS Nano 2021, 15, 11, 17137–17149. DOI: 10.1021/acsnano.1c06839