The US health regulator on Tuesday issued an emergency use authorisation 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 Organisation continues to classify the disease as a public health emergency of international concern, which is its highest level of alert. The US has also declared the disease a public health emergency.