The company, Rapid Bio, is a resident of the biomedical technologies cluster of the Skolkovo Foundation and recently received a product license from the Federal Service for Surveillance in Healthcare (Roszdravnadzor) for its instant blood test designed to detect SARS-CoV-2 antibodies. It takes 10-15 minutes to do the blood analysis, which has a diagnostic sensitivity of 96%.
With the help of the instant blood test, it will be possible to determine through the immune system whether or not the virus has entered the body.
Anzhey Zhimbiyev: “We worked 24 hours a day, 7 days a week, in our laboratory at the Skolkovo Technopark over the course of three months.” Photo: Rapid Bio.
Rapid Bio set about developing the test for SARS-CoV-2 in February. “We already understood then that the situation threatened to turn into an extraordinary one,” the general director, Anzhey Zhimbiyev, told Sk.ru. “Perhaps we could have moved quicker, but unfortunately the reagents that are now for sale were not available at that time. I wrote a letter to the Ministry of Health, Rospotrebnadzor and Roszdravnadzor, informing them of our plan for this development and asked for support in accessing biomaterial. At the same time we began to actively study the analytics on the coronavirus.”
A crowdfunding platform was launched in order to purchase the expensive reagents and the much-needed two million rubles was raised in less than a week.
Photo: Rapid Bio.
The Skolkovo Foundation in its turn took over customs support to import reagents from China, the United States and Europe in order to secure Rapid Bio specialists’ access to blood samples from patients with confirmed diagnosis; it also communicated with government bodies to speed up the test’s registration as a medical device.
“This project has become a big challenge for our young team of biotechnologists,” Anzhey Zhimbiyev continued. “We worked in our Skolkovo Technopark laboratory 24 hours a day, 7 days a week over the course of 3 months, and we completed the testing device’s development and trials in record time. We thank the Skolkovo Foundation and Technopark for the help with conducting clinical trials, logistics and the customs clearance for the reagents, as well as the informational support under the extreme circumstances of the pandemic. We are also thankful to the Innovation Assistance Foundation and the Industrial Development Foundation of the Republic of Buryatia for financially supporting the organization of high-technology production. We have a big job ahead of us with the production launch itself and the continuation of developments in the field of instant diagnostics.”
Anzhey Zhimbiyev. Photo: Sk.ru.
The testing system is based on detecting the IgM and IgG antibodies utilizing immunochromatographic analysis of biomaterial taken from a patient, explained Natalia Polushkina, the vice-president of the Foundation and the deputy director of the Skolkovo Biomedical Technologies Cluster. Capillary blood can be used for the test, which means the study can be performed at the patient’s bedside or at home. The time it takes to do the analysis is 10-15 minutes, but the diagnostic sensitivity is 96%.
“The appearance of a new test on the Russian market, which is the result of the synergistic work of the Skolkovo Foundation and Rapid Bio company, will combat the spread of infection quicker and more effectively, protecting the healthcare bodies and ordinary citizens with the volume of testing systems that are necessary during a pandemic,” said Nataliya Polushkina.
The instant tests for detecting SARS-CoV-2 antibodies will be produced at the base of the Skolkovo Foundation resident company DRD.