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Genetron Health declares CE Marking for its COVID-19 testing kit

Genetron Health declares CE Marking for its COVID-19 testing kit

Chinese precision oncology firm Genetron Holdings Limited, has reportedly declared that it has received the CE marking for its Detection Kit for COVID-19 (SARS-CoV-2) RNA (PCR-Fluorescence Probing). Apparently the FDA-EUA has also accepted the application of this independently developed kit. On the basis of the detection kit, three of Genetron’s clinical laboratories have successfully passed the COVID-19 EQA (External Quality Assessment) conducted by China’s NCCL (National Center for Clinical Laboratories).

As per sources familiar with the knowledge of the matter, apart from achieving the milestone of the application acceptance of FDA-EUA and the CE marking, the nucleic acid detection kit of Genetron Health also seems to have performed very well, in a verification project conducted by the Chinese Center for Disease Control and Prevention, Beijing. Apparently the kit is liable to ensure highly comprehensive, efficient, accurate, and rather safe testing for large-scale samples.

Incidentally, Genetron’s latest aerosol particle sampler (for lower respiratory tracts) has also been sent for application – for clinical verification and medical equipment approval. The company hopes that it would help in controlling the COVID-19 pandemic.

It has been revealed that the GENETRON S5 semiconductor sequencer with high throughput, as well as other supporting instruments, have been donated to the Wuhan Huoshenshan Hospital. Presently, it is the Huoshenshan Hospital’s singularly available MGS (next-generation sequencing) platform, and can perform highly accurate molecular tests of myriad clinical samples so as to yield a comprehensive genomic data. This data is highly instrumental in the clinical and epidemiology research studies of the present and future, in monitoring the virus mutations, battling the disease, and managing and preventing the same.

For the record, the GENETRON S5 sequencing platform also complements the current PCR test very effectively and efficiently, thereby enhancing reliable testing for any weak positive cases, but in very less time. Additionally, it is known to help in the diagnosis of numerous co-infections and also support follow-up precision treatment.


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Nandita Bhardwaj

Nandita holds a management degree with specialization in marketing, and boasts of a short-term experience in the field of recruitment. Following her passion for writing however, she decided to pursue a career in the field of content development. Presently, Nandita pens down news pieces for, spanning the verticals of business, finance, and technology.