Fastgene vs pathogens aka RT PCR on chip: A valorization success story

1) Simple definition of Fastgene?
Fastgene is a microfluidic PCR-on-chip system that enables real-time detection of pathogens to be reduced to a matter of minutes rather than hours and enables the rapid detection of viruses and bacteria, including Ebola or Bacillus anthracis, through small amounts of sample. 

2) What was the reason Fastgene was invented?
The initial issue was misleadingly straightforward: what would happen to be able to regulate the temperature at the second scale in microchannels? Based on that concept, the group discovered that microfluidics, with its very large surface to volume ratios, could heat and cool PCR mixtures much quicker than other tools. It was the basis of Fastgene: a system designed to eliminate the thermal-cycling bottleneck in PCR, and to make molecular diagnostics really high-speed. 

3) The real mechanism of microfluidic PCR-on-chip at Fastgene?
Fastgene does not have to cycle a complete metal block or large well plate, but it forces a little liquid plug through microfluidic chambers, the temperature of which is kept at a very constant level. The system can use 30 PCR cycles in approximately 2 minutes on chip using ultra-efficiency thermalization. It has an inbuilt real-time qPCR readout (fluorescence) and thus you do not just get amplification you get a direct indication of when the target pathogen is present and at what level. 

4) What is the rate of it relative to traditional PCR systems?
The Fastgene system has been shown to identify pathogens in 7-8 minutes and has been validated in Ebola and Anthrax surrogates and is roughly 7-14 times faster than conventional off-the-shelf qPCR tools. Notably, it is this dramatic time gain that comes without the cost in terms of sensitivity or amplification efficiency: detection limits and amplification curves are comparable to the state of the art commercial systems. 

5) Does acceleration undermine performance of the assay (sensitivity, efficiency)?
No. Direct comparisons indicate that Fastgene matches high-end benchtop qPCR systems in terms of molecular detection efficiency and limit of detection, but is even faster than them in most applications, by up to 6 times. The actual technical success of the project is that balance: ultrafast cycling and the quality of qPCR was normal. 

6) What are the types of pathogens that Fastgene is able to identify?
The platform is aimed at capturing short sequences of nucleic acids of both bacteria and virus. In proof of concept Fastgene has been able to identify Ebola and Anthrax variants in under 10 minutes, and it is agnostic in that any pathogen that you can design a qPCR assay (primers/probes) can theoretically be adapted to the chip. This makes it appealing to epidemic preparedness, biodefence, on the one hand, but to more mundane infectious-disease diagnostics, on the other. 

7) What were the steps this technology followed to achieve valorization success story?
Fastgene was originally a research project in the very beginning of the history of Elveflow and MIC and developed almost ten years. The microfluidic thermalization system underneath was patented circa 2010, and funded in 2012 by the French Ministry of Defence (DGA), and later developed together with ENS Paris. In 2014, the technology was the winner of the “Innovation 2030 Worldwide Challenge” and this was an indication that the technology has ceased being an academic whim to be considered as an innovation. To industrialize the platform in order to make prompt molecular diagnostics BforCure was a separate company established in 2018. 

8) What was the role of Fastgene during the situation with COVID-19 and response to epidemics?
One of the strongest candidates to use in pandemic was the capability of Fastgene to detect nucleic acids within several minutes. BforCure, the successor of Fastgene, was chosen by the French Ministry of Armed Forces under the NOMORECOV project with a 1800000 euro grant targeted at point-of-care COVID-19 tests within under 30 minutes in areas such as airports, hospitals or office doors. The bigger picture is evident: the future outbreak should have the same speed and ubiquity of a temperature check. 

9) How is the performance of Fastgene particularly microfluidic?
Microfluidic thermalization is the main key. The system is able to produce very fast and uniform temperature change by confining the PCR mix into micro-scale geometries and driving it at high-performance pressure controllers. This is the reason why Fastgene is capable of doing 30 cycles within a few minutes and maintaining amplification curves clean. Microfluidics also decreases the usage of reagents and allows the use of compact and rugged instruments which can be deployed in the field and not just central laboratories. 

10) What are the project personnel and organizations?
Fastgene is based on Elvesys/MIC ecosystem. The central group is composed of microfluidics and thermics and fluidics specialists, electronics engineers, molecular biologists and optics engineers, such as Mael Le Berre (later founder of BforCure) and Walter Minnella in electronics and optics. At the institutional level, the DGA has helped the project, has been a partner at ENS Paris, and the project has been featured extensively in French media and innovation awards. 

11) What can the European consortia or industrial partners do with Fastgene now?
Today, Fastgene is a developed ultrafast qPCR-on-chip system that demonstrates its performance in regard to high-risk pathogens. A national project or a Horizon Europe project can:
-customize the system to new panels ( respiratory sepsis antimicrobial-resistance genes),
-implement it into epidemic surveillance networks that are decentralized,
-or integrate it into mobile, battery driven platforms of field diagnostics.
MIC is capable of doing microfluidic design, thermalization engineering, system integration and prototype delivery, and partners come with clinical samples, epidemiology and regulatory pathways. Practice in numerous European calls indicates that the consortia with MIC are more likely to increase by perhaps two times their success in making proposals compared to official Horizon averages, in large part because reviewers believe in the synergy of effective engineering and moderate valorisation strategies.

12) Is Fastgene a high-stakes epidemics-only company, or can it apply to ordinary diagnostics as well?
It is both. Its initial impetus was the crises such as the 2014 Ebola outbreak when the lack of fast diagnostics made the problem of containment almost unfeasible. However, when you have a platform capable of performing high quality qPCR in a few minutes then the same device becomes appealing to routine infectious disease diagnostics and hospital workflows, and even occupational health screening. That is, the ultrastiff microfluidic backbone used by epidemic preparedness and daily medicine may be identical.