- The Montpellier Skin Cell start-up has been working since March at the development of a saliva test called EasyCOV. From four drops of saliva, it allows to say in 28 minutes if you are a carrier of the coronavirus.
- Marketable since June 2020, it just got its refund, which should make it easier to deploy.
- It is currently available in the lab, at a doctor’s or at the hospital and recommended only for symptomatic patients when nasopharyngeal sampling is impossible or difficult. But the HAS assessment is called into question and the start-up is continuing its studies in the hope of seeing these recommendations evolve.
We were promised them in September. But they were still long overdue. While France fears a new rebound in the epidemic and will have to wait long months before the vaccination protects the population, the deployment of saliva tests passes (finally!) the second. An order published this Tuesday in Official Journal authorizes the reimbursement of tests Easycov . After some doubts, the start-up Skin Cell, which developed this innovation in partnership with the
National Center for Scientific Research , announcement to 20 Minutes that this test with saliva sample is now reimbursed.
The start-up, like the Directorate General of Health, we ensures that the ministry has not planned to order. On the other hand, this reimbursement should encourage many caregivers and structures to obtain it. “I think this reimbursement will open the door, welcomes Alexandra Prieux, president of Skin Cell. For many people, the nasopharyngeal sample is difficult to do: very young children, the elderly who are very at risk, people with hadicap. There may be a real plus to screening today. “
A simple and possible self-sampling test
The Easycov test starts from a saliva sample to use a technology called RT-LAMP. Basically, instead of sticking a swab up to the eyes, you have to take four drops of saliva under the tongue “because you are closest to the salivary gland, which is very rich in virus,” explains Alexandra Prieux. Then the process is done in two steps. First a pre-treatment of saliva at 75 ° C, then amplification at 40 ° C for thirty minutes. »We therefore obtain a result in 28 minutes, as a color change: fluorescent yellow for positive, orange for negative.
This test therefore avoids the waiting time for RT-PCRs, the pain and apprehension of a nasopharyngeal sample, and allows self-sampling. However, it always requires the presence of a caregiver or a biologist. It is, for the moment, only accessible in doctors’ offices, hospitals or laboratories, but not in pharmacies.
“We have already done simulations to see how to do flow in the field. During an exercise in an airport, we had shown that our organization made it possible to test 190 people in one hour, or passengers of an A 310 ”, emphasizes the president. An illustration that can be transposed to a high school, a company, an nursing home, a nursing home for the disabled … “We only need a relatively quiet and clean room, an electrical outlet, a caregiver or a biologist, who can manage a lot of tests at the same time “, summarizes Alexandra Prieux.
Six months late ?
Now let’s go back to the calendar. The test has been ready for six months. “We obtained the CE marking the 24 June, blows the president of the start-up. Since then, we have been selling abroad, in Europe and in Africa, and it is not for lack of wanting to speed things up in France. I regret that it took so long. »
However, from the summer, Olivier Véran had banged his fist on the table so that the deployment of this saliva test could be accelerated. A study has been launched by the PA -HP in August. Ongoing. But the Montpellier University Hospital picked up the baby on the way, because, unfortunately, the number of Covid patients had increased on the spot. On October 5, the double-blind clinical trial shows that Easycov is able to detect SARS-CoV-2 RNA in less than 28 minutes with a sensitivity of 75 , 9% on 270 topics. We still have to wait for the 27 November for the Haute Autorité de Santé (HAS) to publish its opinion. In mid-December, EasyCov is listed on the ministry’s website among the approved tests. We are just a few days away from the end of year vacation. It will therefore be necessary to wait until January 5 2020 to that the test be reimbursed, and probably deployed within a few days.
Why such restrictive use?
The calendar is not the only one to ask questions . In its opinion, the HAS proposes a particularly restrictive use . The test is in fact authorized “only in symptomatic patients for whom nasopharyngeal sampling is impossible or difficult to perform. In the event of a positive test, a control by an RT-PCR test on a saliva sample is necessary, given the specificity of the easycov test. “
According to the HAS, this test could identify positive patients, but less negative ones:” the performances are satisfactory in terms of clinical sensitivity (84% ) but not satisfactory in terms of clinical specificity (86%) in relation to the minimum required performance (clinical sensitivity of 75% and clinical specificity of 92%) ”. Incomprehensible for Eric Billy, researcher in immuno-oncology and member of the collective On the side of science . Who was also moved by this mess
in an article on the collective’s website. “The scandal is twofold. First, we should not compare the tests on their effectiveness, because each test has a defined field of action, explains the researcher. There, side ease, we do not do better. “It is therefore easy to repeat it every week, for example for caregivers who go to nursing homes.
Second problem,” the HAS compared oranges and lemons : the result of a PCR test after a nasopharyngeal sample and Esasycov. The two tests will have results of different sensitivity since they are two different methods, continues the researcher. While between a PCR on a saliva sample and Easycov, the two techniques obtained almost the same results. “
Confirmation from the Montpellier start-up:” On our clinical study, we arrive at a sensitivity of 86% and a specificity of 99%, so we are beyond the vast majority of antigenic tests ”, assures Alexandra Prieux. Who adds: “Studies show that the virus appears earlier in saliva than in the nose. “
” Nobody understands that this tool is not used while it is simple, French, so no risk of shortage, and inexpensive “, annoys Eric Billy. Same impatience on the part of the mayor of Mulhouse, who demanded from 24 December its deployment in high schools and cultural places.
In addition, the General Directorate of Health, contacted by 20 Minutes , leaves a door open to an enlargement: “Scientifically, the next stages could be determined by new evaluation data, likely to change the current recommendations ”. Indeed, the start-up is continuing its studies, hoping to prove that this test could effectively identify asymptomatics. “Will the HAS change its opinion ?, continues Alexandra Prieux. We hope so and we are working hard with her in this direction. “