After launching their research-use-only test for monkeypox internationally this past July, BD and its Spain-based diagnostic partner CerTest Biotec are bringing their PCR assay to U.S. shores.
The automated lab test—based on CerTest’s Viasure platform and designed for use on the BD MAX system—aims to give researchers another option for tracking the spread of the virus, which this year has logged nearly 25,000 positive cases across the U.S. and about 40,000 cases outside the country, according to the Centers for Disease Control and Prevention (CDC).
In a release, BD said it is working to submit a monkeypox test application to the FDA for an emergency authorization to allow it to be used in the clinic. According to the company, the installed base of the BD MAX system saw "explosive growth" during the COVID-19 pandemic, and BD hopes to leverage its flexible system for future emerging outbreaks like monkeypox.
BD and CerTest first announced plans to collaborate on a PCR test in early June. Built off the BD MAX’s open-reagent approach, the test kit comes freeze-dried and includes a tube designed to snap into BD’s extraction strips for loading into the analyzer.
The research-use-only test joins similar offerings from Roche and Qiagen, among others. Roche launched a trio of diagnostics in late May, not long after monkeypox was first confirmed in a U.S. patient, through its TIB Molbiol subsidiary that it acquired last year.
Qiagen, meanwhile, put forward a six-in-one test that screens for monkeypox alongside other pathogens that may produce similar-looking symptoms, such as herpes simplex virus 1 and 2, human herpesvirus 6, enterovirus and the varicella-zoster virus that causes chickenpox and shingles.
On the clinical side, earlier this month the FDA granted its first and so far only emergency authorization to a PCR test developed by Quest Diagnostics.
Labcorp, meanwhile, was tapped this summer to process samples for the CDC’s own orthopoxvirus test, which is designed to detect all non-smallpox-related bugs in the family, which includes cowpox, horsepox and camelpox along with monkeypox.