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The US Food and Drug Administration (FDA) has granted an emergency use authorisation (EUA) to Fosun Pharma for its Covid-19 RT-PCR detection kit.
The kit enables the qualitative detection of novel coronavirus RNA by targeting its specific ORF1ab, N and E genes. It supports fast automatic nucleic acid extraction instrument and extraction reagents and can complete the detection of 96 samples in less than two hours.
Fosun Pharma noted that automated testing can reduce the risk of operator infection and the probability of cross-contamination in clinical laboratories. Moreover, it will also help to improve detection efficiency.
Developed by the company’s wholly owned subsidiary Fosun Long March, the Covid-19 detection kit secured CE certification from the EU.
It also received the medical device registration certificate issued by the China National Medical Products Administration (NMPA).
Last month, Fosun Pharma initiated a strategic development and commercialisation collaboration with BioNTech for the prevention of Covid-19 infections.
Both companies will work together on the development of Covid-19 vaccines based on BioNTech’s mRNA technology platform in China.
Additionally, they will conduct clinical trials in China, using Fosun Pharma’s clinical development, as well as regulatory and commercial capabilities in the country.
Founded in 1994, Fosun Pharma specialises in PCR hepatitis B virus diagnostic reagents. Currently, the company has a comprehensive medical diagnosis product line with a nationwide marketing network in China.
The product line covers biochemical diagnosis, immune diagnosis, molecular diagnosis and microbial diagnosis, POCT and mass spectrometry, and third-party detection service products.