FDA Issues Emergency Authorization for Roche’s Monkeypox Test

The pharmaceutical company, Roche Holding AG, received emergency use authorization (EUA) from the FDA Tuesday for its cobas MPXV test that successfully detected monkeypox in human trials. The test is one of the few to gain EUA in the United States.

The cobas MPXV test uses PCR technology to detect DNA from the monkeypox virus. Samples will be run through Roche’s cobas 6800/8800 system, which can provide results in 3.5 hours. MPXV tests are only authorized to be analyzed in laboratories certified under the Clinical Laboratory Improvement Amendments that can perform high-complexity tests.

To be tested using Roche’s cobas MPXV, individuals must have visible lesions that can be swabbed to take samples.

“When multiple clusters of monkeypox virus infection were initially reported in countries where the disease is not endemic, Roche was among the first companies to address virus concerns with test kits,” said Thomas Schinecker, CEO of Roche Diagnostics. "To meet the testing needs and workflow demands of laboratories as well as expand access to safe and reliable diagnostic solutions, we developed the cobas MPXV on the fully automated and high-throughput cobas 6800/8800 system."

Monkeypox is a zoonotic viral disease previously endemic to parts of central and west Africa. It is transmitted through close contact with infected persons and tends to be self-limited. Monkeypox is usually not diagnosed based on symptoms alone, and clinicians rely on tests to conclusively determine if a patient has the virus.

Vaccines used to inoculate for smallpox have also shown effectiveness at protecting against monkeypox transmission. The ACAM2000 and HYNNEOS vaccines have been licensed to prevent monkeypox, and in May 2022, the US began to increase its stockpile of these vaccines.

The World Health Organization (WHO) declared monkeypox a public health crisis in late July 2022 as cases cropped up in 75 countries. At the time, there were at least 16,000 reported cases worldwide and 2,891 reported cases in the US.

At the end of August, the first monkeypox-related death was reported in the US, and in the two and half months since, at least nine more people have died due to causes related to the virus.

The US case count now stands at 29,055, according to CDC data. In September 2022, the CDC reported that monkeypox infections were beginning to slow in the US as awareness grew among vulnerable populations. As of November, CDC and WHO officials continue to classify the disease as a public health emergency.