Commercial launch of monkeypox PCR test for research use in laboratories worldwide

September 26, 2022 - 3 minutes
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A newly developed molecular polymerase chain reaction (PCR) test for monkeypox is now commercially available globally for research use only applications.

Becton, Dickinson and Company (BD) and CerTest Biotec made the announcement today (September 26) that the test can be used in laboratories.

The teams leveraged the BD MAX System open architecture reagent suite to develop the CerTest VIASURE Monkeypox molecular research use only assay.

Emergency use authorization

Becton Dickinson and Company is working to submit a clinical test for monkeypox virus for emergency used authorization (EUA) as soon as possible, based on guidance issued by the U.S. Food and Drug Administration (FDA) on September 7.

Nikos Pavlidis, vice president of Molecular Diagnostics at BD, said: “Even before the U.S. Department of Health and Human Services and the FDA declared the ongoing monkeypox outbreak in the United States a public health emergency, we were working with CerTest to quickly develop a molecular assay to help better understand and track the disease.

“Due to the COVID-19 pandemic, the installed base of our BD MAX System experienced explosive growth, providing greater access to this unique, open-architecture system that enables rapid response to emerging health threats like monkeypox.”

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Monkeypox research: capacity boost

The BD MAX System family is a fully integrated, automated platform that performs nucleic acid extraction and real-time PCR providing results for up to 24 samples across multiple syndromes in less than three hours.

BD offers an extensive menu of tests on the system covering health care associated infections, respiratory infections, sexually transmitted infections, gastrointestinal infections and women’s health.

“This new test boosts capacity for monkeypox research and surveillance of this global health emergency,” said Nelson Fernandes, managing director of CerTest Biotec.

“The value of the BD MAX open systems architecture and its ability to speed research and development continues to be critical.”

Rare infection

As with all CerTest assays, the CerTest VIASURE Monkeypox virus PCR Detection RUO assay for the BD MAX System is offered in a lyophilized format. Accordingly, the assay will come in a tube that snaps into the test-specific position on the BD MAX ExK TNA extraction strip, which is supplied by BD.

Monkeypox symptoms usually start within three weeks of exposure to the virus. The illness typically lasts 2-4 weeks. It is a rare infection most commonly found in west or central Africa. There has recently been an increase in cases in the UK, but the risk of catching it is low.

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Monkeypox can be passed on from person to person through any close physical contact with monkeypox blisters or scabs including during sexual contact, kissing, cuddling or holding hands, touching clothing, bedding or towels used by someone with monkeypox or the coughs or sneezes of a person with monkeypox when they’re close to you.

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