Tags: monkeypox | test | swab | roche | fda | authorization | emergency use

FDA Authorizes Roche's Monkeypox Test

Roche on smartphone screen
(Dreamstime)

Wednesday, 16 November 2022 07:17 AM EST

The U.S. health regulator on Tuesday issued an emergency use authorization to Roche's test for the detection of DNA from monkeypox virus in swab specimens collected from people suspected of the virus infection.

The tests will be conducted on the Swiss company's cobas systems, which can also detect HIV, hepatitis B and C viruses.

The Food and Drug Administration said testing will be limited to laboratories that meet the requirements to perform moderate or high complexity tests.

While around 80,000 cases of monkeypox have been reported in nearly 100 countries since the outbreak started earlier this year, the number of cases have declined from the peak in August. Over 28,000 cases have been reported in the United States in the outbreak this year, including two deaths.

The World Health Organization continues to classify the disease as a public health emergency of international concern, which is its highest level of alert. The U.S. has also declared the disease a public health emergency. 

© 2025 Thomson/Reuters. All rights reserved.


Health-News
The U.S. health regulator on Tuesday issued an emergency use authorization to Roche's test for the detection of DNA from monkeypox virus in swab specimens collected from people suspected of the virus infection. The tests will be conducted on the Swiss company's cobas...
monkeypox, test, swab, roche, fda, authorization, emergency use
161
2022-17-16
Wednesday, 16 November 2022 07:17 AM
Newsmax Media, Inc.

Sign up for Newsmax’s Daily Newsletter

Receive breaking news and original analysis - sent right to your inbox.

(Optional for Local News)
Privacy: We never share your email address.
Join the Newsmax Community
Read and Post Comments
Please review Community Guidelines before posting a comment.
 
Find Your Condition
Get Newsmax Text Alerts
TOP

The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Read Newsmax Terms and Conditions of Service.

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved
NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved