Securities code: Bgi Genomics Co.Ltd(300676) securities abbreviation: Bgi Genomics Co.Ltd(300676) Announcement No.: 2022029 Bgi Genomics Co.Ltd(300676)
About covid-19 antigen detection products of the holding subsidiary
Announcement on the change of medical device registration certificate
The company and all members of the board of directors guarantee that the information disclosed is true, accurate and complete without false records, misleading statements or major omissions.
Bgi Genomics Co.Ltd(300676) (hereinafter referred to as the company) holding subsidiary Shenzhen Huada Yinyuan Pharmaceutical Technology Co., Ltd. (hereinafter referred to as Huada Yinyuan) recently obtained the document of change in registration of medical devices of the people’s Republic of China (in vitro diagnostic reagent) issued by the State Drug Administration (hereinafter referred to as the state Drug Administration), The registration certificate of vid-19 medical device has been changed. The details are as follows:
1、 Basic information of certified products
The change of the registration certificate of medical devices for covid-19 antigen detection products of Huada Yinyuan mainly refers to the change of the expected use, instructions, storage conditions and validity period of the products in accordance with the application scheme for covid-19 virus antigen detection (Trial) and other relevant national regulations, The following is the product name: New Coronavirus (2019-nCoV) antigen detection kit (fluorescence immunochromatography) registered person name Shenzhen Huada source Medicine Technology Co., Ltd. Registration Certificate No. 20203400940 registration classification III category approval date March 12, 2022
1. Intended use “This product is used for detection of New Coronavirus N antigen in New Coronavirus infected pneumonia suspected throat throat swabs and nasopharyngeal swabs samples. Antigen detection is generally used for acute infection period, that is, sample detection within 7 days of symptoms of suspected people. Antigen detection can not be used alone for diagnosis of New Coronavirus infection, and nucleic acid examination should be combined. Other diagnostic information such as measurement and imaging, medical history and contact history to judge the infection status. The positive results of antigen detection can be used for early shunting and rapid management of suspected people, but the positive results only indicate that New Coronavirus N antigen exists in the samples, which can not be used as a diagnostic basis for new coronavirus infection. Negative results can not exclude New Coronavirus infection, nor should it be used alone as a basis for treatment and disease management decisions. Further nucleic acid testing should be carried out for antigen positive and negative results of suspected people. This product shall not be used for screening of general population. This product should be used by professionals in professional laboratories. To carry out New Coronavirus antigen detection, we should comply with the requirements of “New Coronavirus infection laboratory testing technical guidelines for pneumonia” and so on, and do a good job in biosafety.
The product was used for the in vitro qualitative detection of New Coronavirus (2019-n) CoV N antigen in the throat swab and nasopharyngeal swab samples of suspected pneumonia patients. It can be applied to the population.
It shall be implemented in accordance with the application scheme for covid-19 virus antigen detection (Trial Implementation) and other relevant national regulations. This product can not be used alone for the diagnosis of New Coronavirus infection. It should be combined with nucleic acid detection, imaging and other diagnostic information and history, contact history to determine the infection status. The positive results can be used for early shunting and rapid management of suspected populations, but positive results only indicate that New Coronavirus antigen exists in the samples, which can not be used as a diagnostic basis for New Coronavirus infection. Negative results can not exclude New Coronavirus infection, nor should it be used alone as a basis for treatment and disease management decisions. Further nucleic acid testing should be carried out for antigen positive and negative results of suspected people. The test positive subjects should report and isolate according to the local epidemic prevention and control policy, and seek corresponding medical help; Test negative subjects should strictly comply with the local epidemic prevention and control requirements, and further take other more sensitive detection methods for confirmation if necessary. If they are still negative, they should continue to monitor and seek medical help in time. The product use environment shall comply with relevant national regulations such as covid-19 virus antigen detection application scheme (Trial). “
2. Change of product storage conditions and validity period, and change of product instructions.
2、 Market situation of certified products
Antigen detection is directly aimed at the specific protein (i.e. antigen) in the virus. It can quickly detect positive cases in the acute infection period. It can be used as a supplementary detection method for specific population screening, which is conducive to improving the ability of “early detection”, and plays an important role in optimizing covid-19 virus detection strategy and overall epidemic prevention and control.
The above certified products need to be adapted to the dry fluorescence immunoanalyzer. The test results have high stability and specificity, and have the advantages of automatic interpretation of test results and information management of test samples.
3、 Impact on the company and risk tips
The change of medical device registration certificate increases the scope of application of covid-19 antigen detection products from Huada Yinyuan, helps to meet the diversified detection scenarios of overall epidemic prevention and control, and helps to improve the comprehensive competitiveness of the company. The actual sales of the above products are affected by policies, market competition, covid-19 epidemic development and other factors. At present, the company is unable to predict its impact on the company’s future performance. Please pay attention to the investment risk. It is hereby announced.
Bgi Genomics Co.Ltd(300676) board of directors March 14, 2022
