FOSUN LONG MARCH'S COVID-19 RT-PCR Detection Kit Receives FDA EUA

Datetime:

2020-04-20 12:40:19

SHANGHAI, April 19, 2020 According to the website of the U.S. Food and Drug Administration ('FDA'), Shanghai Fosun Pharmaceutical (Group) Co., Ltd ('Fosun Pharma'; Stock Code: 600196.SH, 02196.HK) has received emergency use authorization (EUA) from FDA for its COVID-19 RT-PCR detection kit.


The testing kit which was self-developed by Shanghai Fosun Long March Medical Science Co.,Ltd , a wholly-owned subsidiary of Fosun Pharma, has received the medical device registration certificate issued by the China National Medical Products Administration (NMPA) and granted CE certification from the European Union ('EU'). This kit can realize qualitative detection of novel coronavirus RNA targeting for its specific ORF1ab, N and E gene, and can complete the detection of 96 samples within two hours by supporting fast automatic nucleic acid extraction instrument and extraction reagents. In addition, automated testing will lower the risk of operator infection, reduce the probability of cross contamination in the clinical laboratory, and improve detection efficiency.


Fosun Pharma has been engaged in the business of PCR hepatitis B virus diagnostic reagents since its establishment in 1994. Currently, its medical diagnosis product line is relatively comprehensive, covering biochemical diagnosis, immune diagnosis, molecular diagnosis and microbial diagnosis, POCT and mass spectrometry, and third-party detection service products, with a nationwide marketing network in China.