The Department of Health and Human Services will allow emergency use authorizations to be granted for monkeypox diagnostics in efforts to expand the availability of tests as the virus continues to spread in the U.S.
The move, announced Wednesday afternoon, gives the Food and Drug Administration the power to issue EUAs for in vitro diagnostic tests for monkeypox.
The HHS’ decision follows the declaration of a public health emergency for the monkeypox outbreak on Aug. 4.
“Today’s action is an important step forward in our monkeypox response by allowing the FDA to facilitate the development of more validated monkeypox tests and expand access to testing,” HHS Secretary Xavier Becerra said in a Wednesday press release.
As of Wednesday, there were 21,274 cases confirmed in the U.S. and 56,026 cases globally, according to the Centers for Disease Control and Prevention.
Currently, testing capacity in the U.S. has increased to more than 80,000 tests per week, the HHS said. As of Wednesday, there was about 86% testing capacity available, according to the CDC.
Increasing testing has been a priority as the monkeypox virus has spread across the country. The HHS, through the CDC, partnered with five diagnostics companies to increase testing capacity, including Labcorp, Quest Diagnostics and Mayo Clinic Laboratories.
However, experts have also cautioned that there are still access issues, saying there are similar problems as the COVID-19 pandemic, such as confusion over where patients can get tests.
The HHS is invoking powers under section 564 of the Federal Food, Drug, and Cosmetic Act.
