The companies made the diagnostic available outside of the U.S. for use in research applications by laboratories in July. The molecular polymerase chain reaction (PCR) assay is now available globally for research applications only.
Franklin Lakes, New Jersey-based BD and Zaragoza, Spain-based CerTest announced a partnership to develop the test in June.
The CDC began tracking a monkeypox outbreak in the United States and other countries that don’t normally report cases of the infectious virus earlier this year. Monkeypox is said to cause a rash and lesions and is mainly shared through direct physical contact. The CDC warns it can also be transmitted via respiratory secretions during prolonged, face-to-face contact.
To date, the CDC reports 24,846 U.S. monkeypox cases and one related death. It also reports 65,415 cases globally.
BD and CerTest leveraged the BD Max system’s open architecture reagent suite to develop the CerTest ViaSure monkeypox assay. BD plans to submit a clinical test for the virus for FDA emergency use authorization (EUA) “as soon as possible.” The effort is based on guidance issued by the FDA on Sept. 7, the companies said in a news release.
BD, CerTest work to “quickly develop” assay
“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, VP of molecular diagnostics at BD. “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.”
BD Max, a fully integrated, automated platform, performs nucleic acid extraction and real-time PCR testing. It provides results for up to 24 samples across multiple syndromes in less than three hours.
The companies offer the CerTest ViaSure monkeypox PCR assay for BD Max in a lyophilized format. The companies said it comes in a tube that snaps into the test-specific position on the platform’s extraction strip, supplied by BD.
“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.”