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February 5, 2020

FDA approves emergency use of coronavirus diagnostic test

The US Food and Drug Administration (FDA) has issued emergency use authorisation (EUA) of a diagnostic test for the novel coronavirus, reported to infect more than 24,000 people and kill over 400 since emerging in China in December 2019.

Follow the latest updates of the outbreak on our timeline.

The US Food and Drug Administration (FDA) has issued emergency use authorisation (EUA) of a diagnostic test for the novel coronavirus, reported to infect more than 24,000 people and kill over 400 since emerging in China in December 2019.

Developed by the Centers for Disease Control and Prevention (CDC), the 2019-nCoV Real-Time RT-PCR diagnostic panel is a test that has previously been limited only to CDC laboratories.

The latest authorisation from the FDA will enable to use of the test at any CDC-qualified lab across the country.

The US Government recently declared a public health emergency even though the threat of the coronavirus in the US remains relatively low according to the federal health officials.

CDC’s diagnostic panel is a reverse transcriptase-polymerase chain reaction (PCR) test that provides possible detection of 2019-nCoV from respiratory secretions like nasal or oral swabs.

A positive test result suggests likely infection with 2019-nCoV. Authorities urged infected individuals to work with their healthcare provider to manage their symptoms and to better protect the people around them.

The US regulator warned that negative results don’t necessarily preclude an infection, with the test primarily used as a tool alongside clinical observations, patient history and epidemiological information.

FDA Commissioner Stephen Hahn said: “Since this outbreak first emerged, we’ve been working closely with our partners across the US government and around the globe to expedite the development and availability of critical medical products to help end this outbreak as quickly as possible. This continues to be an evolving situation and the ability to distribute this diagnostic test to qualified labs is a critical step forward in protecting public health.”

Last month, Primerdesign, the molecular diagnostics division of Clinical diagnostics company Novacyt, launched a molecular research use only (RUO) test for coronavirus. However, it is capable of detecting only the 2019 strain of the virus.

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