Roszdravnadzor included Genetico Center (Genetics and Reproductive Medicine Center, MOEX: GECO) in the list of medical organizations authorized to conduct laboratory and clinical laboratory trials of medical devices for their registration in the EAEU countries.
Information about Genetico Center has been submitted to the Eurasian Economic Commission using the EAEU integrated information system tools.
Genetico Center is an Artgen Biotech group company (ex. Human Stem Cell Institute, MOEX: ABIO), a resident of Skolkovo, Technopark Medtech. The company works in the field of medical genetics and genetic research, implementing into medical practice innovative solutions for the diagnosis, prevention, and treatment of genetic and socially significant diseases.
According to Sergey Masyuk, Artgen Biotech’s CEO: “Production and circulation of medical devices within the Eurasian Economic Union requires their state registration, one of the stages of which is the clinical and laboratory trials by organizations authorized to conduct them by Roszdravnadzor. Now Genetico Center can act as a contract platform for conducting trials on new medical devices in order to assess their safety and clinical effectiveness for their registration and further circulation in Russia, Armenia, Belarus, Kazakhstan, and Kyrgyzstan.”
Circulation of medical devices in the EAEU is regulated by the Eurasian Economic Union Treaty of May 29, 2014 and the Agreement on Common Principles and Rules for the Circulation of Medical Devices of December 23, 2014, effective since February 12, 2016.
On April 25, 2023, during its IPO on the Moscow Exchange, Genetico offered 10 million shares and raised RUB 178.8 million. The order book was oversubscribed by 2.5 times. Genetico’s shares are listed as high-tech economy sector securities.