FDA authorizes proprietary Monkeypox test for Emergency Use

The EUA is the first granted to a commercially available monkeypox test in the United States. On September 7, the Department of Health and Human Services declared that the public health emergency countermeasures now extend to monkeypox testing.

Quest launched the Quest Monkeypox PCR test nationwide on July 13, 2022. The company performs the test at its advanced laboratories in San Juan Capistrano, Calif., and, beginning last week, Chantilly, VA, for ready access for providers and patients on both coasts of the United States. New York's Department of Health has approved the tests from both laboratories, enabling access for patients living in the state..

Developed with the understanding that viruses mutate, the Quest Monkeypox PCR Test features the ability to detect two different DNA targets (Monkeypox and non-variola Orthopoxvirus DNA) to help protect against false negatives. On September 2, the Centers for Disease Control and Prevention issued a Lab Alert that certain monkeypox tests may fail to detect monkeypox infection when a rare deletion of the target gene (called tumor necrosis factor) occurs, and negative results for highly suspicious cases therefore require confirmation by the CDC or public health labs. The alert does not apply to the Quest Monkeypox PCR test, so Quest does not need to modify its test or refer specimens producing negative results to the CDC or public health labs for confirmation.