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Thermo Fisher Scientific, First Genetics to Develop NGS-Based Diagnostics in Russia

NEW YORK – Thermo Fisher Scientific and First Genetics said on Monday that they are collaborating to commercialize next-gen sequencing-based diagnostics in Russia.

Under the strategic partnership, First Genetics, a Russian manufacturer of diagnostic equipment and IVD kits, will market its F-Genetics NGS System and IVD assays to Russian laboratories for reproductive health testing and cancer diagnostics. The F-Genetics system is based on Thermo Fisher's Ion GeneStudio S5 sequencer.

First Genetics said it has already received its first registration certificate for an IVD kit from the Russian medical device regulatory agency, Roszdravnadzor. The agency approved its kit, Reproline, for detecting chromosomal abnormalities in embryos prior to implantation using the F-Genetics NGS System. The company said that preimplantation genetic testing for aneuploidies (PGT-A) had previously not been certified in Russia and that Russian prenatal centers can now use PGT-A.

Nikolai Kuznetsov, CEO of First Genetics, said in a statement that the firm intends to offer certified solutions for other clinical applications, such as oncology testing.

Thermo Fisher said it has struck similar agreements with other assay developers to expand the use of NGS-based molecular diagnostics in the clinic, which have led to approvals by regulatory agencies in China, the US, and Europe.

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