Innovation

Coronavirus Diagnostic Test Approved By FDA

Amid the current coronavirus outbreak, the Food and Drug Administration (FDA) reportedly issued an expedited approval of a test for the virus and signed off on its use by health labs from different states. According to the FDA, this should help speed up efforts in the country to help detect the virus, which, according to the latest statistics, already affected around 25,000 people from all over the world. Up until the approval of this new diagnostic test, samples from suspected cases in the U.S. has to be sent the Centers for Disease Control and Prevention (CDC) for testing.

According to the FDA, the decision to approve the test under an Emergency Use Authorization and sidestep from its usual regulatory channels is highly critical during this time since it allows use of medical products in life-threatening situations when no approved alternatives are available. The agency previously issued the same emergency authorizations during the onset of other viruses like Zika, Ebola and MERS.

“The ability to distribute this diagnostic test to qualified labs is a critical step forward in protecting the public health,” FDA commissioner Stephen Hahn said in a statement.

Out of the 260 people that have been under investigation for the coronavirus in the United States, only 11 have been confirmed positive while 167 have tested negative, with the remaining 82 cases still pending. While the diagnostic test only takes around four to six hours, the process takes longer since it can take significantly more time for state health departments to ship samples to the CDC central lab in Atlanta, Georgia. The newly approved diagnostic test kit, however, changes that because state labs will now be able to run the tests themselves, speeding up the process.

Last Monday, the CDC first submitted an emergency authorization request to the FDA, with Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, saying at the time that the approval would significantly speed up the current process and expand the country’s ability to test people suspected of having the virus. She added that the test had already been sent to International Reagent Resource as well.

Wuhan Coronavirus Wuhan seafood market closed after the new coronavirus was detected there for the first time on January 1, 2020. SISTEMA 12/Wikimedia Commons

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