FDA Expedites Review of Diagnostic Tests to Combat COVID-19

There has been a long standing shortage of tests worldwide for coronavirus. The U.S. Food and Drug Administration, in another step of unprecedented flexibility to fight coronavirus epidemic, has allowed labs and companies to develop and offer COVID-19 tests throughout United States. This was announced in a statement released from Commissioner of Food and Drugs, FDA, Stephen M. Hahn, M.D.

FDA announced in the press release that all laboratories will have access to Emergency Use Authorization (EUA) pathway. This will enable them to develop and deploy tests quicker in the market. The agency also announced that manufacturers will now have the ability to begin testing before FDA has the chance to check the validity of their data. Right now only 6 laboratories are taking advantage of the unprecedented move. FDA is stressing more companies to follow suit.

FDA has also delegated some of its powers to states. States will now have the ability to develop tests, review their data, and take responsibility for the tests being performed in their area.

The agency is walking on a tight rope between availability of accurate testing facilities en masse and providing a sufficient enough level of oversight. FDA does not develop or distribute tests for diagnostic purposes. Its role is limited to determine if the tests developed by others provide accurate and reliable results.

At the time, only reliable tests should make their way to the public as false negatives and false positives can actually help spread the coronavirus epidemic. FDA is working day and night to ensure any treatments and tests that are developed work effectively. The agency is working with large and small commercial manufacturers at the same time to ensure that everyone who wants a test gets tested.

Where United States is Right Now

The United States is not running enough tests to diagnose coronavirus cases at a larger scale. Take, for example, South Korea where first case was reported on January 21. The country has performed an estimated 4,000 tests per million people. In the U.S., the first case was reported on January 20, and only 5 tests per million people have yet been performed. This is especially bad news since the genome of the virus has been made available since January, and test development just needs a short period of time after genome is sequenced of any virus.

Source: Our World in Data

Testing has been hindered in the country for a variety of reasons, including the flawed testing kits of Centers of Disease Control and Prevention (CDC) that were  made available initially, the reluctance of FDA to approve tests, manufacturing issues, bureaucratic issues, and even President Trump whose wrong statements often conflicted with reality.

Now to reverse all this, FDA is providing expedited approvals for tests. Just three days ago, FDA approved a new test by Abbott Laboratories called Abbott ID NOW COVID-19 test, which can provide positive results in just 5 minutes and negative results in 13 minutes.

Why the Rush for Diagnostic Testing

There is an unprecedented need for diagnosing coronavirus cases by the thousands to ‘flatten the curve’ as well as to ‘shorten the curve’. Social distancing alone won’t help contain this pandemic. Social distancing can only help limit the further spread of the coronavirus by breaking the chain. For diagnosing and isolating people who have already been affected, WHO recommends use of widespread testing.

The problem with this coronavirus infection is that in most people it causes just a mild illness. People who develop the symptoms and are not tested may not take the condition seriously and keep engaging with other people socially. This can spread the virus at an alarming rate. According to experts, every one person who is infected further spreads coronavirus to at least 2.5 people. This exponential growth can overwhelm the health care system and cause widespread deaths. This expedited diagnostic tests approval by FDA is a welcome step to help limit the spread of coronavirus.

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