TestGene develops and manufactures test kits for molecular genetics in the following areas:
- non-invasive genetic prenatal testing;
- cancer testing;
- identification of the mutations associated with targeted therapy;
- kits for nucleic acids isolation from different sources;
- development of kits for genotyping by custom order.
The company has its own production laboratory certified according to ISO 13485:2016 that with the necessary equipment for manufacturing and quality assurance of kits.
The company team of internationally recognized researchers constantly improves the products according to the latest scientific achievements.
Certificates
Certificate ISO 9001:2008 issued by Bureau Veritas Certification Holding SAS (UK Branch) confirms that the Management System of TestGene has been audited and found to be in accordance with the requirements of that management system standard.
Registration certificate № РЗН 2015/2703 of Federal Service on Service on Surveillance in Healthcare and Social Development of Russian Federation.
The first place in the Interactive Competition “Import substitution and Rapid development”
Eurasian patent for an invention
The winner of the Russian Youth Prize in Nanoindustry in 2013
OPORA Russia: the first place of “Business success 2012” in “The best innovative project” category
Semifinal “Zworykin Award 2012”: the best of 1500 inventions
Taiwan Invention Association recognized “Test-RHD” as outstanding invention
Gold Prize at the Seoul International Innovations Fair 2011
Quality Assurance of the Molecular-Pathological Detection of KRAS Mutations in Colorectal Carcinomas
Quality Assurance of the MolecularPathological Detection of RAS Mutations (KRAS, NRAS) in metastatic Colorectal Carcinomas
Quality Assurance of the MolecularPathological Detection of KRAS Mutations in Colorectal Carcinomas
ISO 13485:2003
EN ISO 13485:2012
IQNet ISO 13485
TestGene EAR-Certificate
Test-SRY TD-Review-Certificate
Registration certificate № РЗН 2017/6537 of Federal Service on Service on Surveillance in Healthcare and Social Development of Russian Federation.
Certificate ISO 13485:2016
Certificate IQNet ISO 13485:2016
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