Monkeypox PCR Assay Arrives in U.S. Labs

A new monkeypox virus assay has just been made commercially available for global research applications. BD and CerTest Biotec made the diagnostic available in laboratories outside of the U.S toward the end of July. The two companies, the former based in New Jersey and the latter in Zaragoza, Spain, had made public their test-making partnership a month prior. The CDC has reported just shy of 25,00 monkeypox cases and one related death in the U.S. to date, with the global tally standing at 65,415 cases.

The BD Max system and its open architecture reagent suite were crucial to the development of what is called the CerTest Via Sure monkeypox assay. An FDA emergency use authorization is on the horizon, according to BD, as it plans to submit a clinical test for the virus “as soon as possible.”

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“Even before the U.S. Department of Health and Human Services and Food and Drug Administration 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,” said Nikos Pavlidis, BD’s Vice President of Molecular Diagnostics. “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.”

The BD Max platform facilitates nucleic acid extraction and real-time TCR testing, rendering results for as many as 24 samples in less than three hours. The new CerTest ViaSure monkeypox PCR assay for BD Max will be available in a lyophilized format, in the form of a tube capable of snapping into the test-specific position on the platform’s extraction strip.