A total of 48 new crown test products (reagents + instruments + software) have been approved by the State Food and Drug Administration and 410 new crown export white lists have been issued.
As of July 13,2020, the World Health Organization (WHO) has approved 15 new crown test products worldwide. The FDA has granted emergency authorization for 137 new crown test products worldwide. A total of 48 new crown test products (reagents + instruments + software) have been approved by the State Food and Drug Administration and 410 new Crown Export White lists have been issued by the Chamber of Health Insurance.
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.
Several multinational companies have been certified by WHO EUL and FDA EUA
The same WHO EUL , FDA EUA certification of multinational enterprises are well-known in the Industry Danaher (Saipei, Beckmann) , Roche, Abbott, Siemens, PerkinElmer.
15 New Crown test products listed in WHO EUL list
There are 8 domestic and foreign diagnostic enterprises listed in the WHO EUL list, they are Shuoshi biology, kaipu biology, Zhongsheng Jienuo, kehua biology, Zhijiang biology, Zhuocheng Huisheng, Da'an Gene and Huada Gene.
Foreign Companies Include Roche, Abbott Laboratories, Perkinelmer, pepsico, Siemens, soling, etc. .
Here's the list (in reverse chronological order) :
FDA emergency use authorization for 137 new crown test products
The FDA's approval of China's new crown test products has increased significantly as the U. S. new crown outbreak continues to grow significantly. At present, 137 new crown test products have been approved by the FDA for emergency use, and there are more than 10 domestic and foreign diagnostic enterprises. It is worth mentioning that Hangzhou's enterprise performance is more eye-catching.
Some of the authorized domestic enterprises are as follows:
Beijing Wantai Biopharmaceutical Co. , Ltd.
Date of approval: 10 July
Approved product: WANTAI SARS-COV-2 AB Rapid Test
Hangzhou anxu Biotechnology Co. , Ltd.
Date of approval: 6 July
Approved Product: Assure COVID-19 IGG/IGM Rapid Test Device
Hangzhou Laihe Biotechnology Co. , Ltd.
Date of approval: 19 June
Approved Product: LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (collodidal Gold)
Date of approval: 18 June
Approved Product: COVID-19
Biohan biotechnology (Hefei) Co. , Ltd.
Date of approval: 18 June
Approved Product: Biohit SARS-COV-2 IGM/IGG Antibody Test Kit
Beijing Fanshengzi Gene Technology Co. , Ltd.
Date of approval: 5 June
Approved Product: Genetron SARS-COV-2 RNA Test
Hangzhou botuo Biotechnology Co. , Ltd.
Date of approval: 4 June
Approved Product: Rightsign COVID-19 IGG/IGM Rapid Test Cassette
Oriental Biology (wholly-owned subsidiary US Hengjian Biotechnology Co. , Ltd. .)
Date of approval: 29 May
Approved Product: COVID-19 IGG/IGM Rapid Test Cassette (Whole Blood/Serum/Plasma)
Shengxiang Biotechnology Co. , Ltd.
Date of approval: 4 May
Approved product: Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit
Date of approval: 24 April
Approved Product: ANTI-SARS-COV-2 Rapid Test
Date of approval: 17 April
Approved Product: Fosun COVID-19 RT-PCR Detection Kit
Date of approval: 15 April
Approved Product: SARS-COV-2 FLUORESCENT PCR Kit
Date of approval: 6 April
Approved Product: GNOMEGEN COVID-19 RT-DIGITAL PCR Detection Kit
Beijing Genomics Institute
Date of approval: 26 March
Approved Product: Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2
Antigen, antibody products accounted for about 20%
Among the 137 new crown test products authorized by the FDA EUA, nucleic acid test products are the main products, accounting for about 80% . Antigen, antibody detection products accounted for about 20% .
The major companies approved for antibody testing are:
Beckmann-coulter, Roche, Abbott, Osindo, Antu Biology, Ormon, Siemens, BD, orientals, rahe biology, biota, biota, biota, biogen, Asahi technologies, Diazyme Laboratories, Inc. . , InBios International, Inc. . , Babson Diagnostics, Inc. . EMORY Medical Laboratories, Vibrant America Clinical Labs, Mount Sinai Laboratory, etc. .
The major enterprises approved for Antigen detection products are:
On July 2, the FDA approved Bidi BD's Veritor System for Rapid Detection of SARS-CoV-2, a portable, instant Detection of the COVID-19 antigen that is available within 15 minutes. It is reported that this is the BD company approved the third new crown test products.
On May 8, the FDA approved Quidel Corporation's Sofia 2sars Antigen Fia, the first time an antigenic product has been approved by the FDA.