Rapid Bio, a resident of the Skolkovo Foundation (VEB.RF Group), has received the European CE mark – DE/CA09/0170/R26/IVD/001. The express test for Covid-19 antigens became the first Russian-made test to be registered by the European Union.
The company is planning deliveries to the EU in the near future, where the market in volume terms amounts to hundreds of millions of tests per month. Talks are ongoing with distributors in France, Italy, Latvia, Bulgaria, and Finland. The company is initially planning on sending several million tests monthly with plans to scale up into Africa, Latin America, and Southeast Asia, where the CE mark will speed up getting certification, for which applications have already been submitted.
The Rapid Bio express test detects the presence of the virus within ten minutes using a nasopharynx smear. Thus, the SARS-COV-2 virus antigen is detected through the sample, similar to a PCR test, without requiring additional equipment or laboratory tests.
Arkady Dvorkovich, Chairman of the Skolkovo Foundation:
The Rapid Bio product has already proven its efficacy and that it’s needed in Russia, but entry into the European Union area is the next step towards neutralizing this global threat. The huge capacity of the European market – measured in the hundreds of millions of tests monthly – will allow us to realize the impressive potential of Russian developers of express tests from Skolkovo.
Anzhey Zhimbiev, CEO of Rapid Bio:
We are very pleased that high-tech, Russian-produced medical devices will become available in the European Union. It is an opportunity to contribute to the fight against the global pandemic and promote the results of scientific work by Russian scientists. Our test is one of the most sensitive and high-quality on the global market. We are thankful for the support from the Skolkovo Foundation, the government of the Republic of Buryatia, the Bortnik Foundation, and all those who helped in developing and promoting the tests on the world market.
Previously, Rapid Bio, in collaboration with Avivir, registered the first express test in Russia to detect virus-neutralizing antibodies following vaccination against the coronavirus. It can determine within 15 minutes and with 96% accuracy whether or not there is stable immunity to Covid-19.