C4Diagnostics, Bertin Technologies, and Enalees announce the launch of their clinical trial of BEC-SARS-CoV-2 for humans, a diagnostic test for COVID-19, developed jointly with Pasteur Institute.
The BEC-SARS-CoV-2 for humans test has been submitted to the authorities in accordance with French regulations, the detection process has been validated and a clinical trial has been launched by the consortium in order to obtain CE-IVD marking by the end of September. In the meantime, the test is available as RUO. This diagnostic test relies on two technologies for the extraction of viral RNA and its rapid detection using RT-LAMP. Due to its portable format, it can detect SARSCoV-2 in human on site within 25 minutes (from collection to result) from a nasal or nasopharyngeal swab, with an endogenous control and two different target genes (in line with the World Health Organisation and the French Health Authority (HAS) recommendations).
Laurent Thiery, CEO and co-founder of Enalees, said: "The BEC-SARS-CoV-2 for humans test kit is based on the Enalees test concept that we have been using for two years to detect and curtail the transmission of respiratory diseases, on site, in domestic animals such as horses. In particular, our rapid viral RNA extraction technique validated previously on test kits for animal diseases is at the core of this new test kit. In addition, this test also uses a rapid molecular diagnostic technology based on RTLAMP, used in all Enalees test kits and during previous health crises such as Ebola or Zika by Pasteur Institute. We have adapted our standardised and optimised sample preparation and analysis procedures for human SARS-CoV2 diagnostic test in time to help manage the current health crisis. BEC-SARS-CoV-2 for humans therefore provides a proven solution both in terms of performance and ease of use. This integrated approach highlights the benefits of the One Health approach, combining the best of human, animal, and environmental health."
Younes Lazrak, CEO of C4Diagnostics, added: "While waiting for an effective vaccine against COVID-19, we must expand and facilitate population screening. To cope with the current health crisis, a diagnostic test kit such as BEC-SARS-CoV-2 for humans is particularly suitable for scenarios where access to a diagnostic laboratory is difficult or even impossible, and/or where test results must be determined immediately for on-site testing of asymptomatic individuals who may be potential COVID-19 carriers. The ability to carry out field testing of people in a rapid, easy, and robust way is a major step forward for COVID-19 rapid screening campaigns. The results we have obtained are currently being tested in a prospective clinical trial led by Pasteur Institute in several clinical centres. The clinical data will confirm the sensitivity and specificity of our diagnostic test and we expect that BEC-SARS-CoV-2 for humans will receive its CE-IVD marking by the end of September.”