Rapid test for reliable detection of Delta and Epsilon variants now CE marked
NG Biotech presents Ninonasal®, the COVID-19 antigen self-test that´s detecting Delta and Epsilon variants. (Credit: NG Biotech.)
NG Biotech presents Ninonasal®, the COVID-19 antigen self-test that´s detecting Delta and Epsilon variants. Ninonasal® has obtained the CE mark and can now be marketed across Europe.
The highly sensitive Ninonasal® self-test is performed on nasal samples. Ninonasal®´s superior user friendliness supports the comfortable onsite testing, providing reliable results within minutes before leaving home. It even allows the testing of children under the supervision of adults.
Different from many other rapid tests, Ninonasal® already confirmed its ability to detect the most important variants of concerns clinically in European hospitals. Its unique test design allows the detection of the Alpha, Beta, Gamma, Delta and Epsilon variants. Therefore, Ninonasal® represents a precious and widely accepted tool for easy and frequent testing to detect positive cases and interrupt infections chains.
Obtaining CE marking
The Ninonasal® rapid test already proofed its performance since April 2021 under the special approval for home use from the French health authority. Now, with its CE mark for home use provided by a German notified body, it can be deployed in Europe within the framework of international distribution agreements.
In France, Ninonasal® is assembled into kits and distributed by Boiron Laboratories in order to strengthen its “fully made in France” character.
Milovan Stankov-Pugès, CEO of NG Biotech, says:
“Facing non-standardized local registration processes and products of doubtful quality and origin, distributors and public institutions across Europe were approaching us for help. With Ninonasal®, we did not just launch another rapid antigen test. It’s a solution for all those who understood that there is finally nothing more expensive than a cheap COVID test”.
Source: Company Press Release