Chinese precision oncology firm Genetron Holdings has secured CE mark approval for its independently-developed novel coronavirus (SARS-CoV-2) RNA (PCR-fluorescence probing) detection kit.
The US Food and Drug Administration (FDA) has also accepted emergency use authorisation (EUA) application for the company’s novel coronavirus nucleic acid detection kit.
Genetron’s three clinical laboratories have passed the COVID-19 External Quality Assessment (EQA) based on the test kit from China’s National Center for Clinical Laboratories (NCCL).
The novel coronavirus kit is said to facilitate comprehensive, precise, efficient and safe testing for larger-scale samples, said the company.
Genetron has also applied for medical equipment approval for new aerosol particle sampler
Genetron has also applied for medical equipment approval and clinical verification for its new aerosol particle sampler for lower respiratory tracts.
The company expects its new aerosol particle sampler to help in controlling the SARS-CoV-2 pandemic.
It has also donated GENETRON S5 semiconductor high-throughput sequencer and supporting instruments to Wuhan Huoshenshan Hospital.
The next-generation sequencing (NGS) platform can conduct a precise molecular test of clinical samples to generate comprehensive genomic data.
GENETRON S5 sequencing platform is said to compliment the current PCR test, helping to enhance testing for weak positive cases within a short time. It also supports the diagnosis of any co-infections and support follow-up precision treatment.
In November 2019, Genetron Health secured approval from China’s National Medical Products Administration for Genetron S5 desktop medium-throughput semiconductor-based NGS system for clinical applications.
Genetron Health, which works with more than 400 hospitals and dozens of biopharmaceutical firms, aims to offer one-stop genomic profiling solutions for multiple scenarios that cover early screening, diagnosis and monitoring.
-NS Medical Devices