New Roche coronavirus test wins emergency US approval

The US Food and Drug Administration (FDA) has issued emergency authorisation for a faster coronavirus test made by Swiss diagnostics maker Roche.
The move is aimed at boosting screening capacity to help contain the growing epidemic.
The new tests provide results in three and a half hours and can produce up to 4,128 results daily, the Basel-based company said today, a boost to tests the company has offered until now.
The FDA’s Emergency Use Authorisation clears the tests to be deployed in the US and markets accepting the CE mark showing they conform to European standards.

US testing was hampered by flawed kits distributed by the federal government in February, which gave some false results.
That set the country back in containing an outbreak that has infected more than 122,000 people worldwide and more than 1,660 in the US.
Roche said it is “going to the limits of our production capacity” to deliver as many of the faster tests as possible.
“The virus is infecting people in an exponential way. We knew we had to go to the high through-put systems,” Roche Diagnostics head Thomas Schinecker said.
“This will help isolate patients who are infected, so you can keep the others healthy,” he added.
Schinecker said Roche is in talks with the US Centers for Disease Control and Prevention (CDS) over deploying more systems where they are most needed.
RTE
 

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