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.
You may also be interested in...
At an 11 March FDA budget hearing, US FDA Commissioner Stephen Hahn renewed his request for legislation to require medtech manufacturers to report to FDA any anticipated or existing shortages of devices.
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.