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Novogene Tumor NGS Polygene Test Kit Was Approved to be Listed

On August 13,the"People EGFR,KRAS,BRAF,PIL3CA,ALK and ROS1 gene mutation detection kit"(Semiconductor Sequencing Method)(hereafter referred to as"multi-genes detection kit")of Tianjin Novogene Bioinformatics Technology Co.,Ltd.(hereafter referred to as Novogene)is approved by the State Drug Administration to be listed on the market as III-type medical apparatus and instrument products.The product is mainly used for detecting the mutation status of six genes closely relevant to targeted therapy in tumor tissues of patients with non-small cell lung cancer(NSCLC)in order to select patients suitable for receiving targeted drug therapy.

Compared to the traditional gene detection means,multi-genes detection kit is more simple and convenient.And it just needs one copy of tissue sample,and one piece of detection can just cover multiple tumors to cure relevant genes and achieve point mutation,inserting missing,integration and much other detection of deviant forms so as to supply more comprehensive targeted therapy solutions for doctors and patients.The multi-gene detection kit has been clinically verified through 3086 samples in 5 specialized hospitals and research centers such as Beijing Cancer Hospital and Beijing Chest Hospital.And the result shows that the total compliance rate surpasses 95%.

Novogene was established in 2014 and is situated in Wuqing development area and it belongs to wholly-owned subsidiary of Beijing Novegene Biological Information Technology Co.,Ltd.Currently the business scope of Novogene covers three fields including technology service,tumour gene detection and transgenic detection and it is equipped with Tianjin Novegene GMP workshop,III-type medical equipment production workshop and Novo medical lab.It owns plants,R&D and quality inspection lab.certified by ISO9001 and ISO13485 and other quality management system as well as strong research and development strength,reasonable staffing and strong innovation ability.Since its establishment,it has successfully declared"Digital PCR Chip Reader","People EGFR,KRAS,BRAF,PIK3CA,ALK,ROS1 Gene Mutation Detection Kit(Semiconductor Sequencing Method)"and its supporting software"Cancer Gene Data Processing Software"and other medical device products.Novegene is significantly supported by Wuqing area as a medical instrument production enterprise,Tianjin medical instrument inspector training base as well as 2017 Tianjin Rest Assured Medical Instrument Production Enterprise A-class enterprise.


Release Time:2018-08-22 08:38:15