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C4Diagnostics Receives CE Marking of C4Covid-19 Human

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C4Diagnostics, a French biotech developing innovative Invitro diagnostic tests for infectious diseases, announced today the CE marking and commercialization of C4Covid-19 HumanTM 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 HumanTM is an in vitro diagnostic test (IVD) designed to address the growing 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-analyzer, and the result is delivered in less than 30 minutes.

“The CE marking of our C4Covid-19 HumanTM 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 HumanTM 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”, stated Younes Lazrak, CEO of C4Diagnostics.

“C4Covid-19 HumanTM is the result of our team’s hard work and dedication, but also of extensive collaborations with our partners. Already adopted by our first target customers, the C4Covid-19 HumanTM test is being marketed with a gradual and controlled increase in production to rapidly meet the need in France, Europe, as well as in the Middle East and North Africa”, commented Thomas Tran, Managing Director at C4Diagnostics.

“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 HumanTM test completes our testing capabilities as we also need saliva-based rapid tests to extend Covid-19 screening to specific populations. The C4Covid-19 HumanTM test allows us to offer on the field a quality of analysis comparable to that of the laboratory”, declared Dr Farid Mersali, medical biologist, principal investigator of the clinical trial, and general manager of Synlab Provence Laboratories.

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