FDA Grants Emergency Authorization for First Coronavirus Diagnostic Test

The US Food and Drug Administration (FDA) has issued emergency authorization for a test to detect the novel coronavirus. This virus has killed 500 people in six weeks and more than 20,000 are currently infected from it.

This new test which was previously only performed in laboratories would now be available to public diagnostic labs nationwide. This approval from the FDA has skipped the standard time and approach usually taken by the federal regulatory agency. As the disease is spreading, a commonly available diagnostic test for coronavirus was much needed.  Commissioner FDA, Mr. Stephen Hahn said that;

“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.”

Within these two weeks of a viral outbreak, Chinese health authorities have quarantined nearly 35 million people within Wuhan and its surrounding areas. The cases continue to increase every day and the medical facilities in these areas lack diagnostic kits and treatment supplies.

Also read- World Health Organization Says Coronavirus is NOT a Pandemic

The viral transmission from person to person also continues as the coronavirus cases outside China are circulating in international media. Researchers and health officials around the globe are now working on a joint purpose to develop diagnostic facilities for this virus.

The emergency authorization by the FDA would allow this CDC based test kit to be available in all qualified labs of the world. This diagnostic kit has been already sent to a repository from where anyone can order and purchase it.

This news is highly significant in the USA because the hospitals and healthcare units can now use this basic kit instead of mailing the samples to the CDC for verification. This way the viral outbreak in the USA could be controlled in time.

This emergency authorization is a historic event because previously, during the MERS outbreak in Saudi Arabia, the FDA didn’t issue this authorization for a few months. Likewise, in the case of the Zina virus, it took more than six months after the viral outbreak in Brazil.

The health officials are now taking these public health threats seriously and working to take timely steps to control the spread. This emergency authorization also indicates that they have started to learn ways to deal with new health challenges.

Also read- A New Gear May Save You from Coronavirus

Catharina Boehme is the CEO of a nonprofit Foundation in Geneva that works for Innovative New Diagnostics (FIND). In collaboration with the World Health Organization, it evaluates all new testing tools and technologies to maximize their efficacy and expand their capacity. She says that;

“Outbreaks have become the new norm. There’s been a real cultural shift in how we deal with outbreaks toward more transparency and sharing,”

Right now, this need for diagnostic tests is higher in hospitals and clinics in China. The local lab capacity in virus affected areas is stretched and the healthcare system is oversaturated. In comparison to the USA, there are only 11 cases of coronavirus in the USA so far.

While in China, 500 people have lost their lives and thousands of others are on the verge of health failure. Boehme says that she has not seen any outbreak that is evolving such quickly. So there might be a huge demand for these coronavirus diagnostic kits in the short term. Anyways, the countries should join hands with each other to collectively overcome this coronavirus outbreak.



Areeba Hussain

The author is a fulltime medical and healthcare writer. She graduated in Medical Microbiology and Immunology with distinction. Her areas of prime interest are medicine, medical technology, disease awareness, and research analysis. Twitter @Areeba94789300

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