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Thermo Fisher Scientific and First Genetics JCS partner to develop next-generation sequencing-based diagnostics

Thermo Fisher Scientific

The agreement allows First Genetics to bring its F-Genetics NGS system and in vitro diagnostic assays for reproductive health testing to Russian labs

14 Jul 2020
Diane Li
Assistant Editor

Industry news

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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Data AnalysisData analysis hardware and software is available to make data processing straight-forward yet powerful. Data software can be used for math and stats, technical graphing and image analysis. In addition, software is available for specific data analysis of electrophoresis, densitometry, ELISA and DNA sequencing.HematologyIn Haematology / Hematology, complete blood cell counts (or full blood counts) are obtained using automated blood count analyzers to enumerate blood cell types.  Hematology also encompasses haemostasis and coagulation, thrombophilia and hemophilia, plasma viscosity and ESR analysis, hemoglobinopathies, cell morphology and haematinic measurement.Cellular PathologyCellular Pathology deals with the microscopic analysis of tissue samples and cells. Sample preparation and processing includes fixation, staining, sectioning and slide mounting, using equipment such microtomes and cryostats. 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Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.Clinical GeneticsMolecular Genetics covers the analysis of hereditary genetic disease and chromosomal abnormalities. Genetics can be analysed using DNA, RNA, and protein microarrays, PCR, RT PCR and DNA sequencing. Genetic equipment includes genetic workstations, thermal cyclers, cooling blocks and electrophoresis products. Diagnostic kits are used for DNA / RNA extraction and purification.Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. 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