FDA Issues Emergency Authorization For 2019 Novel Coronavirus Diagnostic

The US Food and Drug Administration (FDA) has issued an emergency use authorization on February 4, 2020, to expand use of a 2019 novel coronavirus (2019-nCoV) diagnostic panel.

The Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel was previously only authorized for use in CDC laboratories. The new authorization allows use of the test at any CDC qualified lab in the nation.

An emergency use authorization allows an unapproved medical product to be used in an emergency when there are not adequate and available alternatives already approved.

The diagnostic is a reverse transcriptase polymerase chain reaction (PCR) test. The test can be administered using common methods of collecting respiratory secretions such as oral and nasal swabs.

“A positive test result indicates likely infection with 2019-nCoV and infected patients should work with their health care provider to manage their symptoms and determine how to best protect the people around them. Negative results do not preclude 2019-nCoV infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history and epidemiological information,” FDA officials wrote.

FDA officials noted the January 31 announcement that Alex Azar, Secretary of the US Department of Health and Human Services (HHS) signed a public health emergency declaration in response to 2019-nCoV. While officials believe the risk of infection for US residents is still low, the declaration indicates a desire on the part of public health officials to coordinate a robust prevention and control response.

In a technical briefing earlier on February 4, World Health Organization (WHO) director-general Tedros Adhanom Ghebreyesus, PhD, announced that there were 20,471 cases of 2019-nCoV confirmed in China at the time, including 425 deaths.

On January 30, WHO declared a public health emergency of international concern just days after declining to do so, a move which reflects the rapidly evolving nature of the outbreak situation.

Contagion® will continue to follow the situation and provide updates as the 2019-nCoV response continues.