FDA issues emergency use authorisation for their first 2019 novel coronavirus diagnostic

The Centres for Disease Control and Prevention’s (CDC) 2019-nCov Real-Time RT-PCR Diagnostic Panel has been approved for use across the US.

The majority of patients with confirmed 2019-nCoV infection have symptoms of acute respiratory illness such as cough and breathing difficulty. However, due to the limited availability of clinical information, it has been difficult to determine the full spectrum of the illness.

The diagnostic panel is a reverse transcriptase polymerase chain reaction (PCR) test that provides presumptive detection of the 2019-nCoV from nasal or oral swabs. It is worth noting that negative results do not preclude the 2019-nCoV infection and should not be used as the sole determinant of clinical diagnosis. Both positive and negative results must be combined with clinical observations, patient history and epidemiological data.

The Department of Health and Human Services (HHS) have determined that the coronavirus (2019-nCoV) outbreak, originating in China, constitutes a public health emergency, as it has the potential to affect national security and health of US citizens, therefore issuing an emergency use authorisation (EUA) based on scientific data. Past EUA’s have included diagnostics for the Zika and Ebola virus outbreaks.

For additional information on the possible treatments for the 2019-nCoV, including the potential for repurposing existing antiviral medicines, click here.