CDC’s 2019-nCov Real-Time RT-PCR Diagnostic Panel gets FDA EUA status

The 2019-nCov Real-Time RT-PCR Diagnostic Panel from the Centers for Disease Control and Prevention has been granted an emergency use authorization status by the US Food and Drug Administration (FDA).

It is now the first diagnostic test to be authorized in the US. The EUA status enables the use of 2019-nCov Real-Time RT-PCR Diagnostic Panel from the Centers for Disease Control and Prevention at any CDC-qualified lab across the US.

The 2019-novel Coronavirus is a new type of coronavirus that severely affects the respiratory system in humans and was first detected in December 2019 in China’s Wuhan. (Read coronavirus symptoms in humans)

The 2019-nCov infection cases reported outside of China were due to travelers who returned from Wuhan and other Chinese places.

The novel Coronavirus diagnostic test can be used for patients who meet the CDC criteria for 2019-nCov testing, under the EUA designation.

Coronavirus diagnostic test gets emergency use approval by US FDA

However, the testing is limited to only CDC qualified laboratories which are certified to do high complexity tests.

The n-CoV diagnostic test is a reverse transcriptase polymerase chain reaction test that enables presumptive detection of the virus from respiratory secretions like oral or nasal swabs.

A positive test result confirms the infection with 2019-nCov and those infected patients must be isolated to manage their symptoms and to prevent transmission of the virus to other people.

Alex Azar, Health and Human Services (HHS) secretary announced a health emergency to better deal with novel Coronavirus outbreak.

Stephen M. Hahn – FDA Commissioner said: “Since this outbreak first emerged, we’ve been working closely with our partners across the U.S 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 the public health.

“Our collaboration with the CDC has been vital to rapidly developing and facilitating access to this diagnostic test. The FDA remains deeply committed to utilizing our regulatory tools and leveraging our technical and scientific expertise to advance the availability of critical medical products to respond to this outbreak in the most expeditious, safe and effective manner possible.”

Recently, IDby DNA, a California-based metagenomics technology company claimed that its Explify Respiratory test can detect Wuhan Coronavirus in addition to more than 900 viral, bacterial, fungal, and parasitic pathogens.