C4Diagnostics, a French biotech developing in-vitro diagnostic tests for infectious diseases, has received CE marking for C4Covid-19 Human for the rapid diagnostic of COVID-19 from a saliva sample.
The performance of the test was calculated upon a largescale clinical trial of 1320 participants, carried out in collaboration with Synlab Provence Laboratories. Sensitivity is 86% and specificity is 97.5%.
C4Covid-19 Human is an in vitro diagnostic test (IVD) designed to address the need for saliva-based screening, combining high performance while being deployable outside the clinical laboratory. Based on RT-LAMP technology, which is close to RT-PCR, it requires minimal equipment, namely a portable reader-analyser, and the result is delivered in less than 30 minutes.
Younes Lazrak, CEO of C4Diagnostics, said: “The CE marking of our C4Covid-19 Human test is great news as it offers new perspectives to control the disease spread with painless immediate diagnosis. It is also a significant milestone for C4Diagnostics as C4Covid-19 Human is our first in vitro diagnostic product to be CE marked and on the market for a medical use. We have overcome the usual limitations of LAMP technology and of saliva samples to offer a kit with performances close to those of RT-PCR analysis on nasopharyngeal swabs.”
Dr Farid Mersali, medical biologist, principal investigator of the clinical trial and general manager of Synlab Provence Laboratories, added: “Synlab Provence is perfectly equipped to handle large batches of samples in its laboratories and since the beginning of the pandemic we have tested over 500,000 samples for COVID-19. The C4Covid-19 Human test completes our testing capabilities as we also need saliva-based rapid tests to extend COVID-19 screening to specific populations. The C4Covid-19 Human test allows us to offer on the field a quality of analysis comparable to that of the laboratory.”
