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FDA grants Abbott Emergency Use Authorization for another COVID-19 antibody test

Published on 12/05/20 at 12:45pm
Photo by US Air Force

The FDA has given Emergency Use Authorisation for another COVID-19 diagnostics test for antibodies from Abbott Laboratories.

With this approval, Abbott will have the ability to produce 30 million antibody tests and ship them across the globe by May. It will carry this out through its ARCHITECT and Alinity I platforms and aims to have 60 million tests produced by June.

This action by the FDA follows a previous emergency authorization last month for another Abbott antibody blood test, which has been shipped to the US, UK, India, Italy and Spain. The FDA has now tightened its regulationd for approving these tests, after multiple versions hit the market that were either flawed or did not meet standards that the agency has in place.

So far, this is Abbott’s fourth test to get Emergency Use Authorization by the FDA, and it’s seeking approval by the European Medicines Agency so it can be marketed in Europe. Robert B. Ford, the President and CEO of the company, commented on the tests and said: “Having more options of highly reliable tests across our platforms will help healthcare workers and health officials as they conduct broad scale testing for Covid-19.”

So far Abbott has shipped 1.4 million of its rapid ID NOW tests and is currently manufacturing 50,000 tests per day.

Conor Kavanagh

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