Here the article specifically mentions NG Biotech all-in-one test, can only mean Atomo's device!!
Coronavirus: NG Biotech, the French Thumbnail for serological tests, scores points
By Thuy-Diep Nguyen on 05/27/2020 at 12:37 p.m. Subscribers
In the jungle - and the controversy - of real and false serological tests, the Breton SME plays the disruptive card with an
"all in one" test, reliable and easy to use at the bedside, especially in the emergency room. Its device is among the 23 tests that have just been approved by the health authorities.
NG Biotech, "Little Thumb" frenchy serological tests, intends to impose itself in the yard of the titans with its "all in one" device.Stephane Mahe
They believed it, but it is always better written black on white. Last weekend, the teams of NG Biotech, an SME from Ille-et-Vilaine, were very happy. On Thursday evening the 21st, health authorities included its brand new serological test among the 23 devices approved in France. A valid validation for the industrialist - against a backdrop of controversy and great vagueness about the usefulness and effectiveness of serological tests to detect the immunity of people to Sars-CoV-2.
Named with the name (if not very commercial!) NG-Test® IgG-IgM COVID-19, it is one of the few rapid diagnostic tests (RDTs), designed and produced in France. The green light from the authorities gives a big boost to the legitimacy of the company, which had already won in mid-May the order for 100,000 tests from the Assistance Publique-Hôpitaux de Paris (AP-HP), in addition of those already collected from hospitals in his region.
At the end of March, it was the General Directorate of Armaments (DGA) which provided it with support of one million euros. Enough to help boost its production, when the state and the French dream of knowing the country's immune map - especially in the event of a second wave of the epidemic. A second site, near the first in Guipry (Ille-et-Vilaine), will start soon. "We will be able to deliver two million tests in July and double that at the end of the year," promises Alain Calvo, director of strategic development. In three months, NG Biotech's workforce doubled (70 people). At this rate, it could reach 150 employees by the end of the year.
The Covid-19 definitely offers a great opportunity - and quite a publicity stunt - to this SME expert in innovative diagnostic solutions, created in 2012 by immunologists Alain Calvo and Milovan Stankov, and his son Milovan Stankov Pugès, now CEO . Up to now, NG Biotech has evolved mainly in serological pregnancy and antibiotic resistance tests. His tactics in this market where the giants are called Roche, Abbott or bioMérieux? "Find disruptive innovations that can be extended to other areas", says Alain Calvo. Thus, its patented and CE marked TDR Covid-19 allows a laboratory result to be obtained in fifteen minutes, from a drop of blood. Above all, he uses the same "all in one" principle of his pregnancy test, integrating the lancing device and the blood collector in the same housing. Convenient for testing at the patient's bedside, especially in the emergency room. And reliable: according to the parameters used for serological tests, this test displays a sensitivity rate (its ability to detect even a low antibody level) of 95%, and specificity (its ability to distinguish antibodies specific to Sars-CoV-2 from others) by 100%.
Now authorized to be prescribed and reimbursed, the TDR of NG Biotech will be sold between 10 and 15 euros. On the marketing side, the SME called on its historic partner Eurobio Scientific, another three-color shoe size in the sector, very introduced to the hospital environment. "Distribution is a key factor for a player of this size," said an industry analyst.Other disruptive projects in the drawers
Question: will this Petit Poucet, already present in 50 countries with its other products, impose this test outside of France? "Payers will favor giants, a guarantee of reliability and ability to supply, tackling one of them. We are capable of producing millions of serological tests ... every week."
NG Biotech wants to believe it. Hope to register his device in the United States - even if the FDA, in the jungle of true and false tests, has just damn restrict market access. Above all, she already has other projects in her drawers. A TROD (rapid diagnostic orientation test) version of the Covid-19, which can be performed by the city doctor, the nurse or the pharmacist - as there are for angina. Or a virological test of Sars-CoV-2 with saliva, faster and easier to perform than the usual nasal swabs. With CEA, its historic scientific ally, it is also refining ultrafast tests in antibiotics
https://www.challenges.fr/entreprise/sante-et-pharmacie/coronavirus-comment-ng-biotech-petit-poucet-frenchy-des-tests-serologiques-compte-s-immposer-dans-la-cour-des-titans_711905
