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The FDA on Tuesday authorised the emergency use of the US Centers for Disease Control and Prevention's (CDC) real-time RT-PCR diagnostic panel for the novel coronavirus. FDA Commissioner Stephen Hahn said the 2019-nCoV outbreak "continues to be an evolving situation and the ability to distribute this diagnostic test to qualified laboratories is a critical step forward in protecting the public health."
The test was previously limited to only CDC laboratories, but the emergency use authorisation allows it to be used by CDC-qualified laboratories across the country. According to the FDA, the diagnostic is a reverse transcriptase PCR test that provides presumptive detection of 2019-nCoV from respiratory secretions, such as nasal or oral swabs. "Negative results do not preclude 2019-nCoV infection and should not be used as the sole basis for treatment or other patient management decisions," the agency noted.
Despite the move, the FDA indicated that "at this time, federal health officials continue to believe that the threat to the general American population from this virus is relatively low."
Novacyt recently launched its genesig 2019-nCoV test to identify cases of coronavirus infection, while Co-Diagnostics said it had completed initial work on a screening test for the new strain. Meanwhile, Roche has said it was struggling to deliver diagnostic tests for the coronavirus to cities in China after authorities there imposed travel restrictions.
For related analysis, see The Wider View: How badly will the medtech industry's health suffer from the coronavirus outbreak?
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