Xpert® Mpox Receives Emergency Use Listing by World Health Organization

Point-of-Care Test for Mpox

SUNNYVALE, Calif., Nov. 4, 2024/PRNewswire/ -- Cepheid today announced that The World Health Organization (WHO) has listed Xpert Mpox under its Emergency Use Listing (EUL) procedure. The EUL process assesses the quality, safety, and performance of essential health products, such as diagnostic tests, to guide procurement agencies and WHO Member States in making informed decisions for time-limited emergency procurement.

In February 2023, Xpert Mpox was the first point-of-care test to receive Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration for the detection and/or diagnosis of mpox infection. Polymerase Chain Reaction (PCR) testing, which detects viral DNA, is considered the gold standard for diagnosing mpox infection¹. Xpert Mpox on the GeneXpert Systems provides results for mpox clade II and for non-variola Orthopoxviruses (including mpox clade I and II) from lesion swabs. Results are available in less than 40 minutes, and the test can be performed in decentralizednear-patient settings.

In 2024, 18 countries have reported over 40,000 suspected mpox cases with most remaining unconfirmed due to limited testing capacity, especially in low and middle-income countries. In the Democratic Republic of the Congo-the hardest-hit country-testing has significantly increased in 2024, following efforts to decentralize testing with support from WHO and partners¹.

One of the key signs of mpox infection is fever with development of a maculopapular rash, often appearing as small, raised spots. However, there are many other illnesses, such as chickenpox, measles, bacterial skin infections, syphilis, herpes, and medication-associated allergies that can present with similar symptoms. The World Health Organization recommends that suspected cases of mpox be confirmed with a PCR test run on an appropriate human lesion sample¹.

"Xpert Mpox is the only point-of-care molecular test with WHO Emergency Use Listing (EUL), making it a valuable preparedness and response tool that can be deployed quickly where accurate and actionable information is needed," said Vitor Rocha, president of Cepheid. "Xpert Mpox runs on Cepheid's GeneXpert systems, which have the largest installed base of any molecular diagnostic platform."

For more information on Cepheid's GeneXpert systems or the complete menu of Xpert tests, visit www.cepheid.com.

References:

1. https://www.who.int/news/item/30-10-2024-who-lists-additional-mpox-diagnostic-tests-for-emergency-use
2. https://www.who.int/news-room/fact-sheets/detail/monkeypox

About Cepheid

Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated molecular diagnostic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.

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SOURCE Cepheid