Thermo Fisher Scientific has signed a strategic partnership agreement with Russian diagnostic equipment and IVD kits manufacturer First Genetics to develop next-generation sequencing (NGS)-based diagnostics in Russia.
As part of the agreement, First Genetics will 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 obtained the first registration certificate for an IVD kit by the Russian medical device regulatory agency Roszdravnadzor.
The company has also secured approval for its Reproline kit for use in the diagnosis of chromosomal abnormalities in embryos on the F-Genetics NGS System prior to IVF implantation.
Previously, preimplantation genetic testing for aneuploidies (PGT-A) was not certified in Russia. The certification allows Russian prenatal centres to use PGT-A.
First Genetics CEO Nikolai Kuznetsov said: “High-throughput technologies for genetic analysis are the future of molecular diagnostics.
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“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.”
Meanwhile, Thermo Fisher has signed a number of agreements with various companies to expand the use of NGS-based molecular diagnostics in clinics and to advance precision medicine worldwide.
Similar partnerships with other organisations have led to approvals by regulatory agencies in China, US and Europe, the company said.
Thermo Fisher reproductive health general manager Yan Zhang said: “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.”
“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.”