September 16, 2020, Paris and Marseille – Bertin Technologies, C4Diagnostics & 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 French Ethics Committee1 has given its approval for a prospective clinical trial;
• This prospective clinical trial has been launched in several clinical centres in France;
• The CE-IVD marking is expected by the end of September 2020
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 RUO2. This sensitive, rapid, and portable diagnostic test relies on two innovative technologies for the extraction of viral RNA and its rapid detection using RT-LAMP. Due to its portable format, it can detect SARS-CoV-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 Organization and the French Health Authority (HAS) recommendations).
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