Roche Covid-19 Antibody Test Gets Emergency Green Light From FDA

[perugu_vada]

https://www.bloomberg.com/news/articles/2020-05-03/roche-s-covid-19-antibody-test-gets-fda-emergency-use-approval
 

Roche Holding AG received emergency-use authorization from the U.S. Food and Drug Administration for its new test determining if someone has been exposed to Covid-19, according to a statement on Sunday.

The Basel-based drugmaker said it has already started shipments and that as of May, tens of millions of the antibody test will be available in the U.S. and much of Europe.

Roche’s antibody test has a specificity of more than 99.8% and 100% sensitivity, meaning that it not only reliably identifies patients who’ve developed antibodies but also can filter out those who haven’t, reducing misdiagnoses.