Quest Diagnostics has received US Food and Drug Administration (FDA) emergency use authorization (EUA) for its monkeypox polymerase chain reaction (PCR) test.
The latest move follows a declaration of monkeypox as a public health emergency by the US Department of Health and Human Services.
The Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR (Quest Monkeypox PCR) is claimed to be the first test to receive EUA due to the monkeypox public health emergency.
It has been designed to detect monkeypox virus DNA and non-variola orthopoxvirus DNA in lesion swab samples collected from people with suspected infection by their healthcare provider.
Launched worldwide on 13 July, the lab-developed molecular diagnostic test has been developed with the understanding that the virus will mutate.
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Quest Diagnostics initially performed the tests only at its advanced lab located in San Juan Capistrano, California, however last week the company started performing the tests at its lab in Chantilly, Virginia, as well.
The Department of Health of New York approved the Quest Monkeypox PCR to be performed at both laboratory locations.
Quest Diagnostics medical and chief medical officer, R&D, and senior vice-president Jay Wohlgemuth said: “Quest is committed to developing high-quality diagnostic innovations to help respond to the monkeypox public health emergency.
“With this FDA emergency authorisation, Quest is positioned to complement the response of public health laboratories and help fight the spread of the virus.”
The company noted that the test results need to be used in combination with a patient’s medical history and other diagnostic information.
Last month, Quest Diagnostics introduced a new obstetrics laboratory test panel to screen eligible pregnant women for hepatitis C (HCV) alongside other standard laboratory tests.
