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Huada gene: new crown kit has been authorized by FDA for emergency use and officially entered the U.S. market

via:CnBeta     time:2020/3/28 1:00:33     readed:606

In March 27th, the novel coronavirus nucleic acid detection kit was recently released to the US Food and Drug Administration (FDA) emergency application authorization (EUA) by the Shenzhen international Limited by Share Ltd (hereinafter referred to as the "big gene" 300676) announcement.

The Chinese novel coronavirus SARS-2019-nCoV nucleic acid detection kit (fluorescence PCR method) is called "Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV". The announcement said that novel coronavirus pneumonia was officially marketed in the US clinical market after the commercial sale of the new coronavirus pneumonia under the public crisis diagnosis policy guidelines.

After the outbreak of novel coronavirus, the Chinese gene began to develop the kit in early January 2020, and completed the initial research and development in only 72 hours. After the adoption of strict kit production process and quality control, the new coronavirus nucleic acid detection kit (fluorescent PCR method) was officially announced in January 14th. The approved novel coronavirus nucleic acid test kit has obtained the medical device registration certificate issued by the China National Drug Administration (NMPA) and has been certified by the European Union CE.

According to BGI, the approval of FDA EUA for the company's new crown test product is another milestone for BGI to assist in global epidemic prevention and control.

Up to now, BGI has produced more than 7 million copies of the kit, and has completed nearly 580000 new coronavirus nucleic acid tests across the country, which has been widely used in the anti epidemic "defense war" in Wuhan and Hubei, as well as the nationwide resumption of production and screening work. At present, the kit has covered 70 countries and regions, and has been shipped to Japan, Brunei, Thailand, the United Arab Emirates, Egypt, Peru and other places.

"We have an emergency authorization from the U.S. FDA for the use of COVID-19 test kits, which will help provide the U.S. with high-quality, high-throughput testing services, and the results of nucleic acid testing will help medical professionals respond quickly and assist screening for new coronavirus infections, thus preventing further spread of infection ," said Yin Ye, a genetic CEO at Huada.

It is worth noting that, so far, the United States has become the world's largest number of newly diagnosed cases. According to real-time statistics released by Johns Hopkins University in the United States, as of about 7 a.m. Beijing time on March 27, the United States reported a total of 82404 confirmed cases of new crown pneumonia, the number of confirmed cases ranked first in the world ,1201 deaths. At 7 a.m. the previous day, there were 17119 new confirmed cases and 275 new deaths.

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