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In response to the global outbreak, 15 new crown test products have been added to the WHO EUA list of 137 approved by the FDA
Release time: 2020-08-12 09:41:00  Hits: 7

The World Health Organization (who) has warned that the recent outbreak of new coronavirus is once again accelerating its spread. Globally, the cumulative number of confirmed cases passed 10 million on June 29 to 12 million on July 10 in just 12 days.

As of 6:34 PM GMT 13,12859834 new cases had been confirmed and 567957 deaths had been reported, according to the Johns Hopkins University. The United States is the world's worst affected country, with 3297501 confirmed cases and 135155 deaths.

As some countries began to "unseal", the epidemic has rebounded. Until the new vaccine is officially available, WHO calls on all countries to consistently adopt "whole-of-government, whole-of-society" prevention and control measures.

As of July 13,2020, the World Health Organization (WHO) has approved a total of 15 new crown test products worldwide. The FDA has granted emergency authorization for 137 new crown test products worldwide.

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Two domestic IVD listed companies were certified by Nmpa, WHO EUL and FDA EUA

According to statistics, there are two domestic in vitro and in Vivo diagnostic enterprises which are certified or authorized by NMPA (China State Drug Administration) , FDA EUA (US Food and Drug Administration) and WHO EUL (World Health Organization) respectively, both are listed companies.

Founded in 2010, Shuoshi biological is located in the state-level medical hi-tech Park- China Medical City, Taizhou, Jiangsu Province. December 5,2019 in Shanghai Stock Exchange Science and Innovation Board listed, stock symbol "688399" . The company has multiple fluorescent quantitative PCR, biochip, Enzyme Chemistry and other modern biological technology platform and intelligent equipment platform, engaged in infectious disease, genetic disorder, oncology and other areas of product development, production and sales. In the first quarter of 2020, revenues of affected companies jumped 276.21% from a year earlier, while net profits of shareholders of listed companies soared nearly sevenfold.

On April 16,2020, Shuoshi biological novel coronavirus 2019-nCoV nucleic acid detection kit (fluorescence PCR method) was issued by the State Drug Administration (NMPA) registration certificate of medical devices. On June 18,2020, the 2019-nCoV nucleic acid detection kit (fluorescent PCR method) was granted emergency use authorization by FDA EUA. On July 9,2020, the 2019-nCoV nucleic acid detection kit (fluorescence PCR method) was approved by WHO EUL.

BGI was established in 1999 with the official launch of the "China part" of the International Human Genome Project. July 14,2017 in Shenzhen Stock Exchange business listing, stock symbol "300676" . In the first quarter of 2020, BGI realized business revenue of 791 million yuan, up 35.78 percent year on year, and realized net profit of 140 million yuan, up 42.59 percent year on year.

January 26,2020, huada novel coronavirus 2019-nCoV nucleic acid detection kit (fluorescent PCR) , novel coronavirus 2019-nCoV nucleic acid detection kit (combined probe-anchored polymerase chain reaction) , gene sequencing system and 2019-nCoV nucleic acid analysis software obtained 4 medical device registration certificates issued by the State Drug Administration (NMPA) . On March 26,2020, the 2019-nCoV nucleic acid detection kit (fluorescent PCR method) was approved by FDA for emergency use. On 7 May 2020, the product 2019-nCoV nucleic acid detection kit (FPCR) from the wholly owned subsidiary Bgi Europe a/s was added to the WHO EUL list.

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