On the evening of January 16, Andon Health Co.Ltd(002432) announced that the company learned in the early morning of January 15, 2022 Beijing time that its U.S. subsidiary ihealth’s covid-19 virus antigen rapid detection POC (point of care) professional kit (colloidal gold immunochromatography) was authorized by the U.S. Food and Drug Administration (FDA), And received the authorization letter sent by FDA to the U.S. subsidiary. Thereafter, the product can be used in the United States and countries recognized by FDA EUA during the public health emergency in the United States.
According to the announcement, the product is mainly used for the rapid and qualitative detection of New Coronavirus (SARS-CoV-2) in human nose swab samples in vitro. According to the product instructions, professional medical personnel or personnel skilled in using the kit in the scene of on-site care (POC) shall collect the front nasal swab samples for test operation. The results can be obtained in 15 minutes, which can be used by professional medical personnel and personnel skilled in using the kit in the scene of on-site care in the screening of covid-19 pneumonia, Help epidemic prevention and control.
Andon Health Co.Ltd(002432) said that the product enriches the company’s covid-19 antigen detection product line through emergency use authorization, can contribute to public health and epidemic prevention to a greater extent, provide professional covid-19 virus detection solutions for public health and epidemic prevention, and may bring relevant sales revenue and performance to the company in the future.
However, the company also reminds that the overseas sales of ihealth covid-19 antigen rapid detection POC professional kit of the U.S. subsidiary is closely related to the development of the epidemic. Due to the unpredictability of the epidemic development, the promotion of vaccination plan, the research and development of specific drugs and the validity period of product emergency use authorization, As well as the development and changes of the market and other factors, after the product is authorized for emergency use in the United States, the company is still unable to predict the impact of the product on the company’s operating revenue and performance in the future.
