Beijing-based Genetron Health's novel coronavirus kit receives U.S. EUA approval after receiving CE mark in the European Union
On June 6, Genetron Health announced that its new coronavirus nucleic acid test, Genetron SARS-CoV-2 RNA Test, has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).
Genetron Health's novel coronavirus test has also been included in the China Chamber of Commerce for Import and Export of Medicines and Health Products (CCCMHP) list of novel coronavirus test manufacturers (CCCMHP White List) and is approved for export overseas.
Genetron Health's new coronavirus test has been approved for export to overseas markets. The kit has completed a full set of EU CE marking and has been approved to enter the European market.
In February, Genetron Health announced that it had completed the development of a new nucleic acid test for coronavirus and entered the NMPA's emergency approval process.
According to Genetron Health, the kit is comprehensive, accurate, simple and rapid, and prevents contamination, making it suitable for rapid testing of large samples and enhancing the ability to detect novel coronaviruses.
Genetron Health also said it has provided the novel coronavirus kit to some of the world's most outbreak-prone regions to help them quickly conduct large-scale virus testing.
According to the State Drug Administration's query data, as of June 6, 39 new coronavirus test reagent products have been approved in China, including one protein test kit, 19 antibody test kits and 19 nucleic acid test kits.
Since the end of March, 10 Chinese companies, including BGI Group and Fosun Pharmaceutical, have received EUA approval from the US FDA for their novel coronavirus nucleic acid reagents.
EUA, or Emergency-Use-Administration, was released in early February in response to the shortage of various medical devices in the US, which is a kind of temporary "passport" to market and the fastest way for products to enter the US market.
It is noteworthy that after the FDA announced the end of the epidemic, the products with EUA qualification can no longer be marketed for use and still need to apply for regular registration.