Human Stem Cells Institute Subsidiary, Center for Genetics and Reproductive Medicine Genetico have concluded a license agreement with the Mount Sinai hospital (Icahn School of Medicine at Mount Sinai) for the right to use a highly specific antigen for coronavirus SARS-CoV-2 to develop and commercialize a product for testing infected and those who have survived COVID-19.
HSCI Press Office
Highly Specific Recombinant Antigens for coronavirus SARS-CoV-2 based on its S-protein were developed by American specialists under the guidance of the professor Florian Cramer (preprint of the article on MedRxiv). One antigen was a full-sized trimer of the S-protein, optimized and modified to increase stability, the other is an isolated receptor-binding domain (RBD) of this protein. (S-protein and in particular RBD of other species of coronaviruses, are the main targets of neutralizing antibodies, that is, those that inhibit the reproduction of the virus in the body.)
The researchers tested whether an enzyme-linked immunosorbent analysis could be created on the basis of these antigens to detect antibodies to SARS-CoV-2 in those who are infected or have recovered. Testing on negative control samples collected before COVID-19, including from patients who have had other coronavirus infections, as well as samples of patients with COVID-19, showed that the analyzes will be quite sensitive and specific. An immunological test based on this study received approval for emergency use (EUA) in the United States on April 15.
Currently, the Genetico Center included in the portfolio of RVC Biofund, is engaged in the development and implementation of test systems for detecting immunity to a new coronavirus infection. The main component of such test systems is the coronavirus antigens.
Earlier, the Mount-Sinai hospital for free provided DNA plasmid with a viral protein gene to the scientists from the Institute of Molecular Biology of the Russian Academy of Sciences, where they were the first in Russia to receive this protein and confirm that antibodies interact with it. The same plasmid was handed over to the specialists of the NMRC of Hematology of the
Ministry of Health of the Russian Federation and the FRC of Biotechnology of the Russian Academy of Sciences.
The HSCI and the Genetico Center are facing the challenge of the antigen production on an industrial scale. Therefore, Genetico concluded an agreement with Mount Sinai that the received plasmid could be legally used for commercial purposes: produce the antigen, develop test systems on its basis and make them available in the healthcare market.
According to the Director of Genetico Center Arthur Isaev:
Director of RVC subsidiaries Mikhail Fedotov: