FDA Gives Roche Emergency Use Approval for Antibody Tests

Elias Hubbard
May 5, 2020

United States regulator approves Roche's Covid-19 antibody testMay 3, 2020 - 11:42The US Food and Drug Administration (FDA) has given emergency approval for use of the serological test developed by Swiss pharmaceutical giant Roche, the company announced on Sunday.The test is created to determine whether a person has been exposed to the new coronavirus and developed antibodies against the disease.

"Roche will provide high double-digit millions of tests already in May for countries accepting the CE mark and in the United States under Emergency Use Authorisation, further ramping up capacities thereafter", the company said. (An EUA allows medical products to be used under certain emergency situations, such as the COVID-19 pandemic, without undergoing the typically extensive FDA approval process.) The tests will also be expected to meet specific standards for accuracy.

This comes after the agency faced criticism that it did not act quickly enough with diagnostic tests. A number of these tests were flawed or made unproven claims.

Other companies including US-based Abbott Laboratories, Becton Dickinson and Co, Italy's DiaSorin have also developed tests to identify antibodies that develop after somebody has come into contact with the virus.

Germany has secured millions of coronavirus antibody tests, Berlin announced on Monday, but it will only use them after taking advice from the nation's ethics council.

And a positive test for the presence of coronavirus-fighting antibodies might not necessarily mean local authorities give a person a green light to flout all previous restrictions - meaning many may question why their movements continue to be restricted - while others could inappropriately seek to deliberately infect themselves, should greater freedoms be perceived as on offer to those who have had it and recovered. The agency is also now reviewing more than 200 tests for emergency authorization.

If makers of antibody tests don't submit an EUA application within the 10-day deadline, the FDA will make this information public and may take action to remove the tests from the market, the Post reported.

Other reports by Click Lancashire

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