FDA expedites diagnostic testing for coronavirus

FDA new policy allows labs to use validated COVID019 diagnostics before FDA completes a review of their EUA requests.

The U.S. government is working with the Food and Drugs Administration – FDA to strongly examine the cause of novel coronavirus. Centers for Disease Control and Prevention – CDC being the national partner are helping in closely monitoring an outbreak of the virus. 

Since the virus has been first identified in Wuhan City, China, it is strengthing its grip and gradually attacking human health across the globe. With this vicious spread, the U.S. government contemplates it as a severe public health concern. 

FDA role in the cause

After the weeks of testing for the coronavirus, FDA announced this Sunday that new diagnostic technologies would be shared with all elite hospitals and healthcare centers to do further testing on COVID-19. The FDA is playing a condemnatory role in protecting the U.S. from the dreadful virus. They are working with several interagency partners, product developers, international partners, and global regulators in facilitating the development and availability of medical countermeasures (MCM). The MCM will help in diagnosing the disease and also in its treatment. 

The FDA will give an administration to sponsors for developing the investigational MCMs. This will greatly help in indicating the emerging threats. FDA will also guide and work along with the medical product sponsors to rapidly advance the development of products crucial to conscious efforts. 

The Food and Drug Administration of the United States also monitors fraudulent products in the U.S. market. It takes timely actions to protect the public from consuming all those false products. 

FDA granted Emergency Use Authorization


The FDA department enables access to investigational MCMs through appropriate mechanisms such as Emergency Use Authorization – EUA. Recently, the FDA granted EUA to two public health laboratories in New York to identify COVID-19 and to diagnose public health emergencies through several testing. Prior to the issuance of EUA, the FDA issued the policies for complicated testing performance check for diagnostic testings in certified laboratories under Clinical Laboratory Improvement Amendments – CLIA. 

CDC role in the Coronavirus

The U.S. government is working intimately with the local, tribal, and regional public health partners to deal with this great health risk. These public health partners respond individually to distinguish and limit the introduction of this disease in the United States. Centers for Disease Control and Prevention (CDC) is operationalizing it’s pandemic readiness and reaction plans, taking a shot at numerous fronts to meet these objectives, including explicit measures to prepare the communities for COVID-19 local transmission. 

CDC has issued clinical guidance for health care professionals, for assessing the potential risk of various exposures to COVID-19, for evaluating the patients under investigation and has also updated interim guidance on the outbreak of coronavirus. 

Coronavirus testing in United States

The World Health Organization – WHO – has shipped coronavirus testing kits to around 57 countries. Besides the efforts of WHO, countries like China can do up to 1.6 million tests a week. South Korea has also been able to test on 65000 people so far. However, the CDC has done only 459 tests

Along with a lower number of tests, the test kits designed by CDC contained a non-recommended reagent, and so the tests were not able to be done as fast as they should be. 

Not only the CDC, but a whistleblower also complained about the Department of Health and Human Services on evacuating American citizens from Wuhan without the proper training or protective gear. The whistleblower criticized that she was unfairly dragged into the safety of all those citizens’ health as the HHS staffers were not properly trained and equipped to operate in a public health emergency. The spokesperson of the Special Counsel Office has confirmed that the case has been assigned after receiving the complaint. 

FDA exclusive approval

Now that with the wide-spread of coronavirus fear in public, the FDA is giving a free hand to all the research centers in the U.S. to use the new technologies to develop more health care facilities. With these new facilities, more tests could be possible concerning the COVID-19. 

Dr. Stephen M. Hahn, FDA Commissioner, said in a statement, “We believe this policy strikes the right balance during this public health emergency. We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the U.S. We are not changing our standards for issuing Emergency Use Authorizations. This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation.”

He further said that “This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation.”

The CEO of the Association of Public Health Laboratories, Scott Becker, said in praise of FDA decision that “We are greatly encouraged by expanding the testing capacity to the clinical laboratory community.” 

With this deal, Becker anticipated that by the end of next week, public health labs would be able to break 10,000 tests a day. 

Previously the U.S. administration’s response to the dreadful coronavirus has been quite misleading. Now “we’re ramping up testing,” said Alex Azar, Secretary of Health and Human Services. He claimed, “We now have 75,000 tests available out there in the United States. And over the next week, that will expand radically on top of 75,000 tests available.” 

READ: NASA awarded CAPSTONE CubeSat contract to Rocket Lab

Featured image: FDA

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