Genetron Health Announces Its Novel Coronavirus Nucleic Acid Detection Kit Is CE Marked and FDA-EUA Application Accepted, with Three Laboratories Passing NCCL’s COVID-19 EQA

Release time:2020-04-07

Beijing, 7 April 2020 – Genetron Holdings Limited (“Genetron Health”), a China-based precision oncology company that covers full-cycle cancer care, announces that its independently developed Detection Kit for Novel Coronavirus (SARS-CoV-2) RNA (PCR-Fluorescence Probing) has been issued CE marking and had its application accepted by FDA-EUA. Based on the test kit, three of Genetron Health’s clinical laboratories have passed the COVID-19 External Quality Assessment (EQA) by China’s National Center for Clinical Laboratories (NCCL).


Genetron Health Announces Its Novel Coronavirus Nucleic Acid Detection Kit Is CE Marked and FDA-EUA Application Accepted, with Three Laboratories Passing NCCL’s COVID-19 EQA


Genetron Health’s Novel Coronavirus Nucleic Acid Detection Kit


Genetron Health Announces Its Novel Coronavirus Nucleic Acid Detection Kit Is CE Marked and FDA-EUA Application Accepted, with Three Laboratories Passing NCCL’s COVID-19 EQA

Genetron Health Announces Its Novel Coronavirus Nucleic Acid Detection Kit Is CE Marked and FDA-EUA Application Accepted, with Three Laboratories Passing NCCL’s COVID-19 EQA


EU CE-IVD Marking Certification


In addition to CE marking and FDA-EUA application acceptance, Genetron Health’s nucleic acid detection kit has also performed excellently in a verification project held by the Beijing Center for Disease Prevention and Control. The kit enables comprehensive, accurate, efficient, and safe testing for larger-scale samples. Additionally, Genetron Health's new aerosol particle sampler for lower respiratory tracts has also applied for medical equipment approval and clinical verification, in hopes to help control the SARS-CoV-2 pandemic. 


Moreover, the GENETRON S5 (China National Medical Device Registration 20193220820),  semiconductor high-throughput sequencer, and supporting instruments have been donated to Wuhan Huoshenshan Hospital. As currently Huoshenshan Hospital’s only next-generation sequencing (NGS) platform, it can perform accurate molecular test of clinical samples to yield comprehensive genomic data. Such data is acutely instrumental in current and future clinical and epidemiology research in battling the disease, monitoring mutations of the coronavirus as well as in continuous management and prevention of the COVID-19 outbreak (including formulation of preventive measures, research and development of related diagnostic kits, vaccines and drug treatment).


GENETRON S5 sequencing platform also effectively and efficiently complements the current PCR test, thus enhances reliable testing for weak positive cases using a substantially shorter time. In addition, it can aid diagnosis of any co-infections and support follow-up precision treatment.


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