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HHS Authorizes FDA to Issue EUAs for Monkeypox Tests, Quest Diagnostics Gets First Authorization

NEW YORK – The US Department of Health and Human Services announced on Wednesday that it has authorized the Food and Drug Administration to issue emergency use authorizations for monkeypox tests.

The agency has issued the first EUA for a monkeypox test to Quest Diagnostics, the FDA said in a separate announcement. 

HHS Secretary Xavier Becerra signed a declaration under section 564 of the Federal Food, Drug, and Cosmetic Act to allow the FDA to issue EUAs for in vitro diagnostic tests to detect and/or diagnose monkeypox virus, including tests for non-variola orthopoxvirus.

"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," Becerra said in a statement.

The decision comes one month after the agency declared a public health emergency for monkeypox.

In June, HHS began shipping monkeypox tests to five commercial laboratories to ramp up testing capacity, with current testing capacity at more than 80,000 tests per week, HHS said in a statement. Multiple companies have developed their own monkeypox tests, including CorDx and Anitoa Systems.

Quest received the first EUA for a monkeypox test for its Monkeypox Virus Qualitative Real-Time PCR test, intended for the detection of monkeypox and other non-variola orthopoxvirus DNA with lesion swab specimens, the FDA said. 

In its own separate statement, Quest said the test, which was launched in July, is for the qualitative detective of the virus. The company performs the test at its laboratories in San Juan Capistrano, California, and Chantilly, Virginia. Quest noted that the New York State Department of Health has also approved the test from both labs, allowing the test for use by patients in the state.

The test can detect two different DNA targets, monkeypox and non-variola orthopoxvirus DNA to better rule out false negatives. Last week, the US Centers for Disease Control and Prevention issued an alert saying some monkeypox tests may not detect monkeypox infection when a rare deletion of the target gene occurs. The CDC said that highly suspicious cases that test negative with those tests should be confirmed by the CDC or public health labs. Quest said the alert does not apply to its test.