- The trial has received ethics committee approval
- It is now underway in several French healthcare centers
- CE-IVD marking is expected for the end of September 2020
C4Diagnostics, Bertin Technologies and Enalees have launched a prospective clinical trial for BEC-SARS-CoV-2 for humans, a test developed in partnership with Institut Pasteur to detect the etiological agent of COVID-19.
BEC-SARS-CoV-2 for humans was submitted as required to French regulatory authorities, the detection process was validated and the clinical trial was launched by the partners with the objective of obtaining CE-IVD marking by the end of September.
Currently, the test is available for research use only. The sensitive, rapid and portable test employs reverse transcription loop-mediated isothermal amplification (RT-LAMP), a combination of two innovative technologies to extract and detect viral RNA.
The diagnostic provides results for COVID-19 detection within the 25 minutes following a nasal or nasopharyngeal swab. It comprises an internal control and two targets (in conformity with WHO and HAS recommendations).
Laurent Thiery, Enalees CEO and Co-founder:
“BEC-SARS-CoV-2 for humans is built upon an Enalees concept that, for two years now, has enabled the in-the-filed detection and treatment of respiratory diseases in horses and other domesticated animals. More precisely, the foundation of this new diagnostic is our technology for the rapid extraction of viral RNA, which has already been clinically validated in veterinary medicine. The test also calls upon an RT-LAMP–based rapid molecular diagnostics technology used not only by Enalees, but also by the Institut Pasteur during past health crises such as the Ebola and Zika epidemics. We were able to adapt our standardized and optimized protocols for sample preparation and analysis to human SARS-CoV-2 in a timeframe compatible with the management of the current health crisis. BEC-SARS-CoV-2 for humans offers a solution with demonstrated performance and ease of use. This integrated methodology shines a light on the One Health approach, which associates the best of public, animal and environmental health.”
Younes Lazrak, CEO of C4Diagnostics:
“While awaiting the development of an efficacious vaccine, France needs to increase its capacities in and deployment of testing. We are contributing to the management of the COVID-19 crisis with our diagnostic test, which is particularly pertinent when lab access is difficult or even impossible (when at sea for example) and/or immediate results are needed to test asymptomatic but potentially infected people there where they are. This capacity for testing individuals potentially exposed to COVID-19 on-site and in a matter of minutes is a major breakthrough for accessible screening (in air or rail travel, for example). Our early results are being consolidated today in a prospective, multicenter clinical trial headed by the Institut Pasteur. The trial will measure the specificity and sensitivity of our BEC-SARS-CoV-2 for humans diagnostic test, which we hope to have CE-certified by September. It will further strengthen the range of solutions that C4Diagnostics has been proposing in the fight against COVID-19 since the pandemic began.”
Bruno Vallayer, General Director of Bertin Technologies:
“As do the vast majority of products developed by Bertin Technologies, this French developed and manufactured test meets the most demanding quality standards. BEC-SARS-CoV-2 for humans is complementary to the test we developed and commercialized jointly in May of 2020: BEC-SARS-CoV-2 for the environment. This latter, teamed with the Coriolis biological air sampler, provides a complete solution for environmental contamination analyses. Used as a duo, the two BEC-SARS-CoV-2 tests provide COVID-19 screening both for the environment and for the family, friends and coworkers of an infected person. This two-pronged approach is essential for managing epidemic hotspots in a controlled and localized manner.”