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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.
The Chinese government's plan to reduce tariffs it imposed on a slew of US exports is expected to have minimal impact on the overall medtech industry. See what Ralph Ives, AdvaMed's executive VP for global strategy, said about it here.
The US agency has suspended all routine surveillance inspections in China through the end of March because of coronavirus fears, commissioner Stephen Hahn announced late on 14 February. Despite expecting medical product shortages, Hahn said the agency is being proactive: “We are not waiting for drug and device manufacturers to report shortages to us” before acting. The timing of Hahn’s statement – at 6 p.m. EST on a Friday, at the beginning of a three-day US holiday weekend – suggests he isn’t particularly excited to share the information.
Two top trade experts tell Medtech Insight that China’s recent decision to reduce tariffs is in response to the US government’s announcement that it, too, would reduce tariffs in an apparent bid to deescalate the seemingly never-ending trade war. Dropping tariffs will also help China meet its obligations under a so-called Phase 1 trade deal agreed to by the two countries.
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.
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.
The US agency on 4 February issued its first Emergency Use Authorization of a 2019-novel coronavirus test by enabling emergency use of the Centers for Disease Control and Prevention’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel. The move will allow use of the test at any CDC-qualified lab across the US.
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