CDC Urges Diagnostics Makers To Scale Up Coronavirus Test
The second in command at the US Centers for Disease Control and Prevention said with the help of the Chinese government, the agency was quickly able to develop a diagnostic test for the new coronavirus – but now the private sector should use its resources to scale up production of the tests.
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Novacyt, Co-Diagnostics, Other Test Firms Seek Fast-Track EUA Approval From FDA For Coronavirus Dx's
Diagnostics companies around the world – including Novacyt, Roche, Co-Diagnostics and Mammoth Biosciences – are developing and launching tests to fight the coronavirus in China and other countries as quickly as possible, and some are seeking Emergency Use Authorization (EUA) approval from the FDA so their assays can be used on US patients.
Exports of components and finished medical devices coming from coronavirus-stricken China will continue to flow to the US and other countries for now, but there could be trouble soon if government quarantines and international travel bans remain in place, an industry expert in Shanghai tells Medtech Insight.
A new coronavirus test template developed by the US Centers for Disease Control and Prevention is being refined by the agency so it can be shared with domestic and international partners to help identify more cases of the virus. In the meantime, state labs can use the posted assay for coronavirus on the CDC’s website for testing of residents within their jurisdiction and send results to the CDC.