Labcorp Gets Emergency Authorization from FDA for Home Kit to Detect Monkeypox

By Denny Jacob

Labcorp received emergency use authorization from the Food and Drug Administration for its home testing kit to help detect the virus that causes monkeypox as the number of cases rise.

The laboratory services provider said Wednesday that the authorization comes amid a reported increase in monkeypox cases. There have been 511 cases reported in 2024 through March 16 compared to fewer than 300 cases reported by late March 2023, according to the Centers for Disease Control and Prevention.

The company said the Mpox PCR test home collection kit hasn't been cleared or approved by the FDA but has been cleared for emergency use under an emergency use authorization. An EUA is aimed at facilitating the use and availability of medical countermeasures needed during public health emergencies.

The test is available to physicians to order for patients 18 years or older who are suspected of monkeypox infection.

Write to Denny Jacob at denny.jacob@wsj.com

(END) Dow Jones Newswires

April 10, 2024 07:29 ET (11:29 GMT)

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