Roche Receives US FDA Emergency Use Authorization for Zika Test

By Denise Roland

Roche Holding AG said a Zika virus test developed by its diagnostics unit has received emergency use authorisation from the U.S. Food and Drug Administration.

The Swiss drug maker said the test detects the virus in the blood using its LightMix or cobas z 480 machines, both small and easy-to-use systems.

It is the latest diagnostic test to receive emergency authorisation in the U.S. in response to the threat posed by the Zika virus. The virus can be detected in either the blood or urine.

The FDA grants this status to unapproved products whose use is deemed necessary in public health emergencies.

Roche is already providing a test that screens blood donations for the Zika virus. That test was made available under an investigative new drug program, another route for unapproved products to be made available under special circumstances.

Write to Denise Roland at [e-mail]

(END) Dow Jones Newswires

August 29, 2016 05:09 ET (09:09 GMT)

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