FDA Pushes Through New COVID-19 Test That Can Give Result In 45 Minutes

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“Test, test, test” is the key to containing the COVID-19 pandemic, urged the World Health Organisation's (WHO) director-general Dr Tedros Adhanom Ghebreyesus last week.

In light of this guidance, the US Food and Drug Administration (FDA) has given emergency approval to a new diagnostic test for COVID-19 that can produce a result in just 45 minutes. Cepheid, the California-based company that developed the test, hopes to start rolling out its test to hospitals and medical practices by the end of this month.

“The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30, which is an incredibly rapid timeline for such an effort,” Alex Azar, US Secretary of Health and Human Services, said in a statement on March 21.

To help deal with the continuing test equipment shortages, the FDA used an Emergency Use Authorization to pass the new Cepheid-made tests. This rarely used protocol allows the FDA to allow unapproved medical products or unapproved uses of approved medical products to be used in emergency circumstances.  

However, Cepheid has stressed that the test should only be used in urgent circumstances in hospitals for those who need it most. Its main task, for the time being, is to simply ease pressure on healthcare facilities. 

“We don’t believe this technology should be used, at least initially, in a doctor’s office. This is not a test for the worried well,” David Persing, chief medical officer of Cepheid, told STAT

“It needs to be used very sparingly for patients who really need it and for health care workers who really need it."

The US currently has the third-highest number of confirmed COVID-19 cases in the world, after Italy and China. New York State alone has at least 15,000 confirmed cases as of March 23, more than the whole of South Korea and the UK combined. 

Many have criticized the US government’s response to the ongoing crisis, not least because of the slow and bungled rollout of coronavirus tests, which has seen many hospitals struggling to get their hands on test equipment due to supply shortages, bureaucracy, and politicsWhile there has been a recent ramping up of efforts, many hospitals and medical professionals are still experiencing problems when it comes to acquiring a test.

Testing is a vital tool for understanding and conquering a global viral outbreak. In the words of WHO chief Dr Tedros, not testing for COVID-19 is like a firefighter trying to put out an inferno with a blindfold on. Speaking at a press conference last week, he urged governments to "Test every suspected case. If they test positive isolate them and find out who they have been in close contact with up to two days before they developed symptoms and test those people too."

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