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EasyCOV: French regulator gives its approval

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EasyCOV: French regulator gives its approval

EasyCOV: French regulator gives its approval

 

Press release, December 1, 2020

Another step forward in the wide-scale deployment of the saliva-based test in France and on international markets

On November 27th, 2020, France’s Haute Autorité de Santé (HAS) issued a favourable opinion on the usage and reimbursement of the EasyCOV test on symptomatic patients for whom nasal swabbing is impossible or difficult to perform. The consortium behind the test, comprising the biotech company SKILLCELL (ALCEN Group), the laboratory SYS2DIAG (CNRS/ALCEN) and the company VOGO, are pleased with these initial indications which could be further expanded.

Given this positive decision, EasyCOV is now fully recognised as a relevant tool in strategies to diagnose and detect COVID-19. This new milestone will help accelerate the commercial roll-out of the test in France and on international markets.

Since last March, the Haute Autorité de Santé in France has been carrying out scientific monitoring of tests to diagnose infection with SARS-CoV-2 and continuously assessing the various solutions available. The favourable decision on EasyCOV confirms the benefits of the test in terms of simplicity, speed and efficacy (the Haute Autorité de Santé notice is available here).

As a reminder, EasyCOV is a viral RNA detection tool that is easier and faster (40 min) than RT-PCR testing. The RT-LAMP technique on which EasyCOV is based makes it possible to amplify viral RNA, then reveal its presence in a saliva sample after heating twice at constant temperatures. The results are analysed via a digital application that employs colorimetric reading.

 

Effectiveness confirmed by clinical trial results

The effectiveness of this rapid saliva-based test was just confirmed with the conclusion of the clinical trial led by the teams of the Montpellier University Hospital and the Sys2diag laboratory. Thus, when screening symptomatic and asymptomatic individuals, EasyCOV was proven effective (86 % sensitivity and 99 % specificity) at detecting the virus responsible for COVID-19.

The study results are available here: CP-easycov301120.pdf (cnrs.fr)

 

A launchpad for commercial roll-out in France and on international markets

Driven by the go-ahead from the French regulator, SKILLCELL and VOGO will now be able to ramp up the commercial roll-out of EasyCOV in France, with an emphasis on the markets where the test’s advantages are most compelling: nursing homes, screening events in the field requiring high repetitiveness (sport events in particular), and so on.

The recognition of the test’s suitability by the French regulatory authority will also boost commercial expansion outside France, especially in Africa and south-east Asia where the HAS’s ruling was eagerly awaited.

 

Download the press release of SKILLCELL/CNRS/VOGO here.

 

 

 

 

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