Quest monkeypox test receives FDA emergency use authorization

Earlier this summer, Quest Diagnostics announced that its monkeypox test was available nationwide to help detect the virus. On Sept. 7, the company said the diagnostic received emergency use authorization from the U.S. Food and Drug Administration for use by authorized labs. 

According to the Secaucus-based diagnostics company, it is the first EUA granted to a commercially available monkeypox test in the U.S. On Sept. 7, the U.S. Department of Health and Human Services declared that public health emergency countermeasures now extend to monkeypox testing.

“Quest is committed to developing high-quality diagnostic innovations to help respond to the monkeypox public health emergency,” said Quest’s Dr. Jay Wohlgemuth, senior vice president, R&D, Medical and chief medical officer. “With this FDA emergency authorization, Quest is positioned to complement the response of public health laboratories and help fight the spread of the virus.” 

The company again emphasized that results from the test – officially called the Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR – should be used to help detect the virus in conjunction with patient history and other diagnostic information to determine a patient’s treatment. 

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 be specific) to help protect against false negatives, the company explained. 

The test uses swab specimens collected by health care professionals administered through Quest’s network of physician offices and hospital partners. 

Monkeypox is a rare, infectious disease typically occurring in parts of Africa. However, the West African clade (clade II) is the virus circulating in the current global outbreak.