- Becton Dickinson and CerTest Biotec have made a PCR assay for monkeypox virus available commercially in the U.S. and other markets worldwide.
- The assay currently is only available for research use applications by laboratories. BD said in a statement that it’s working to file a clinical test for emergency use authorization in the U.S. based on guidance issued earlier this month.
- Development of the CerTest Viasure Monkeypox research-use-only assay leveraged BD MAX, an automated platform that performs real-time PCR and delivers results within three hours.
After initially focusing on increasing testing through partnerships between laboratories and the Centers for Disease Control and Prevention, the Department of Health and Human Services opened the door to EUAs for monkeypox tests earlier this month. BD plans to use the newly opened pathway.
BD, working with CerTest, a European developer of diagnostics, launched a monkeypox assay for research use only with a view to securing an EUA to enable clinical use down the line. The rollout could benefit from the BD MAX machines that laboratories installed to test for SARS-CoV-2.
“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,” Nikos Pavlidis, vice president of molecular diagnostics at BD, said in the statement.
The planned clinical rollout of the BD-CerTest assay follows calls by physicians to increase access to tests and for new types of diagnostics. While companies including Labcorp and Quest Diagnostics added capacity, access to monkeypox testing in the U.S. remained constrained over the summer. As of Sept. 26, there had been 25,162 confirmed cases in the U.S., according to the CDC, up from 9,492 on Aug. 9.