Cellex

Cellex

Cellex is a biotechnology company that develops technologies, instruments and diagnostic assays for human diseases and conditions with emphasis on point-of-care settings

Cellex is a biotechnology company that develops technologies, instruments and diagnostic assays for human diseases and conditions with emphasis on point-of-care settings. Cellex’s main R&D staff are located at Research Triangle Park (RTP), North Carolina. The company’s manufacturing facilities are located at RTP an in Suzhou China.

Cellex were the first to have a serological test to detect antibodies to the COVID-19 coronavirus SARS-CoV-2 approved in the US by the FDA under emergency use authorization (EUA) on April 1, 2020. The test analyzes blood samples in authorized labs with a 15-20 minute test that detects two types of antibodies, immunoglobulin M (IgM) and immunoglobulin G (IgG). IgM is the first antibody the body makes to a foreign substance, appearing a few days after infection. The body later produces large quantities of IgG. A positive result can mean a person is currently or was recently infected with SARS-CoV-2.

Timeline

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FDA authorizes Cellex coronavirus antibodies test

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April 3, 2020

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Heather Landi
September 16, 2020
FierceHealthcare
There is a growing consensus among public health officials and business leaders that a widely-accessible rapid antigen testing solution is needed to decrease the public health threat from COVID-19 and mitigate the pandemic's economic impact until a vaccine is widely available.
Jayakrishna Ambati
April 28, 2020
Scientific American Blog Network
Dozens of tests with unknown accuracy have flooded the U.S. thanks to a move by the FDA that loosened restrictions

References

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