Variant detection: CE marking for NG Biotech's antigen tests

The COVID-19 antigenic self-tests developed by the Breton company NG Biotech allow the detection of Delta (Indian) and Epsilon (United States/Mexico) variants that are of concern around the world. They have obtained the CE marking and their marketing is now possible throughout Europe.

A distribution partnership with Boiron Laboratories

In France, the Ninonasal® self-test on nasal swab is already available in pharmacies for use by individuals. Its distribution is ensured by Laboratoires Boiron, as part of an international partnership. The Ministry plans to facilitate access to these tests by expanding their use in hotels, campsites and businesses. The tests are also available to healthcare professionals on nasal swab (Ninonasal ® PRO) and nasopharyngeal swab (NG-Test® SARS-CoV-2 Ag).

Monoclonal antibodies to detect the virus

While the Delta variant raises the risk of widespread contamination and epidemic recovery in Europe, and the Epsilon variant is beginning to cause concern, NG Biotech continues its commitment to the fight against the pandemic with the production of rapid antigen tests used in nasal and nasopharyngeal swabs.
The monoclonal antibodies used in these tests can detect the virus, even in the presence of alpha, beta, gamma, delta and Epsilon variants. They therefore make it possible to meet the current needs for screening for the Delta variant, whose contagion is very strong.

CE marking of the Ninonasal® self-test

The Ninonasal® self-test put on the market in April 2021 with a derogation from the ANSM (National Agency for the Safety of Medicines) has just obtained the CE marking. Its commercialization will therefore be able to be deployed in Europe as part of the international partnership established by NG Biotech with Laboratoires Boiron.

We remain strongly mobilized to support the French and European health authorities in their national screening strategies in order to avoid any new risk of epidemic outbreak that worries all European countries today. Obtaining the CE marking for our antigen test available in professional version and self-test will allow us to meet these new pressing needs. And the use of our serological test before a 1st injection of vaccine also reinforces the vaccination strategy since it avoids a 2nd injection in people who have been infected with the virus. With the extension of vaccination to younger populations who have more often developed asymptomatic forms of the disease, this pre-vaccine testing phase becomes indispensable. »

Milovan Stankov-Pugès, CEO and co-founder of NG Biotech

Published on 12/07/2021