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April 20, 2020

Coronavirus company news summary – South Korean Covid-19 assays make their way to the US – Roche announces development of antibody test

By Chloe Kent

20 April

The US Food and Drug Administration (FDA) has given Emergency Use Authorisation (EUA) for the Covid-19 RT-PCR detection kit by Shanghai Fosun Pharmaceutical. The Fosun Pharma subsidiary Fosun Long March self-developed the testing kit, which received the medical device registration certificate from China National Medical Products Administration (NMPA) and CE certification from European Union (EU). The test can detect the novel coronavirus RNA by targeting its ORF1ab, N and E gene. The test can carry out the detection of 96 samples in less than two hours.

The Covid-19 test kits developed by South Korea-based Osang Healthcare have received the emergency use authorisation by the FDA. This is the first time the FDA has granted emergency approval for a South Korean company. Osang’s GeneFinder Covid-19 Plus RealAmp Kit can be used only in authorised testing labs. This test can identify the presence of nucleic acid for Covid-19 causing coronavirus with mouth and nose swabs.

South Korea-based company SD Biosensor has commenced the manufacturing of rapid antibody test kits in its Manesar plant to detect Covid-19 in India. This move is expected to address the need for testing kits in the country. LiveMint has quoted a person familiar with the development as saying that it received the license from Indian Council of Medical Research for the kit manufacture on 14 April and the Drug Controller General of India on 16 April.

Roche has announced the development and upcoming launch of Elecsys Anti-SARS-CoV-2 serology test for detecting the antibodies of SARS-CoV-2 that causes the Covid-19 disease. The immunoassay uses human serum and plasma from a sample of blood taken from the suspected patient. This test will detect antibodies and determine the immune reaction of the body to SARS-CoV-2. It can also aid in the priority screening of healthcare workers, food supply workers and other high-risk groups who may have developed some immunity against the virus.

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