FDA Gives EUA to CDC Coronavirus Detection Test

FDA has issued an emergency use authorization (EUA) for the Centers for Disease Control and Prevention’s Coronavirus detection test. Up until now, the Prevention’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel has only been used at CDC laboratories.

Under this EUA, the use of the 2019-nCoV Real-Time RT-PCR Diagnostic Panel is authorized for patients who meet the CDC criteria for 2019-nCoV testing.

The diagnostic is a reverse transcriptase-polymerase chain reaction (PCR) test that provides presumptive detection of 2019-nCoV from respiratory secretions, such as nasal or oral swabs

In a release, 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 the public health. Our collaboration with the CDC has been vital to rapidly developing and facilitating access to this diagnostic test.â€

FDA’s EUA comes nearly a week after the agency announced a strategy that would see it working with the industry and international partners to expedite the development and availability of medical products needed to diagnose, treat, mitigate, and prevent coronavirus outbreaks.

A coronavirus is a kind of common virus that causes an infection in the nose, sinuses, or upper throat. Most are not deadly. The World Health Organization identified this new type of coronavirus late last year, which originated in China.

Since then, more than 24,000 cases of coronavirus have been reported worldwide and there are about 490 reported deaths from the disease, according to a report from CNBC. There are now about 11 cases of the virus in the U.S., according to a report from Bloomberg.

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