Thermo Fisher Scientific and First Genetics JCS, a manufacturer of diagnostic equipment and IVD kits intended to advance molecular genetic technologies into clinical practice, today announced a strategic partnership focused on commercializing next-generation sequencing (NGS)–based diagnostics in Russia. The agreement enables First Genetics to market its F-Genetics NGS System and IVD assays to Russian labs for reproductive health testing and cancer diagnostics. The F-Genetics System is based on Thermo Fisher's Ion GeneStudio S5 System.
First Genetics has already received its first registration certificate for an IVD kit by Roszdravnadzor, the Russian medical device regulatory agency. The company's Reproline kit is now approved for detecting chromosomal abnormalities in embryos on the F-Genetics NGS System prior to IVF implantation. While IVF is now government-funded as part of Russia's policy to help boost the national birth rate, preimplantation genetic testing for aneuploidies (PGT-A) had not previously been certified in Russia. The certification now enables Russian prenatal centers, which have doubled in number over the last decade, to leverage PGT-A.
"High-throughput technologies for genetic analysis are the future of molecular diagnostics," said Nikolai Kuznetsov, CEO, First Genetics. "Today we have expanded applications of NGS into reproductive medicine in Russia, and in the future, we intend to offer clinically certified solutions for other clinical applications, such as oncology testing. This is our contribution to the development of clinical diagnostics in Russia."
Thermo Fisher has entered into a number of agreements with assay developers like First Genetics to expand the use of NGS-based molecular diagnostics in the clinic and to advance precision medicine globally. Similar partnerships with other organizations have led to approvals by regulatory agencies in China, the United States and Europe.
"It is our mission to help bring molecular testing to all parts of the world so those who need it most can benefit from the genetic information next-generation sequencing provides," said Yan Zhang, general manager, reproductive health at Thermo Fisher. "We are pleased that couples in Russia now have access to First Genetics' solutions to assist in family planning and reduce the emotional burdens they face while undergoing fertility treatment."
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