Amid the World Health Organization’s declaration of the ongoing monkeypox outbreak as a global health emergency, testmakers are beginning to kick their diagnostics work into high gear.
Latest to throw its hat into the ring is BD, which on Wednesday announced the commercial launch of the monkeypox test it developed with Spain’s CerTest Biotec.
BD and CerTest first shared their plans to collaborate on a PCR test in early June. Just a few weeks later, the resulting diagnostic is now available to researchers outside the U.S., echoing Roche’s launch of its own research-use-only tests for the virus in May.
With that research-only status, BD and CerTest’s assay was designed with an aim of expanding understanding of monkeypox, potentially leading to the development of additional tools that can help stop the spread of the disease.
The test kit arrives freeze-dried and includes a tube that’s specifically designed to snap into the proper position in BD’s extraction strips.
Not only does the CerTest Viasure monkeypox test run on the BD Max molecular diagnostics system, but it was also developed using the technology’s suite of open-system reagents.
“One of the key advantages of the BD Max system is its open-architecture system that enables rapid response to emerging health threats,” said Nikos Pavlidis, BD’s vice president of molecular diagnostics. “Just as we did at the beginning of the COVID-19 pandemic, we partnered with CerTest to quickly develop a molecular test to help better understand and track this disease.”
The BD Max platform is able to run real-time PCR tests on up to two dozen samples at a time, returning results within about three hours.
To date, nearly 20,000 cases of monkeypox have been confirmed in 76 countries around the world—with more than 98% of the cases found in countries that have not historically encountered the disease—according to the most recent data from the U.S. Centers for Disease Control and Prevention.
Those rapidly growing numbers prompted the WHO to name the outbreak a global health emergency and the CDC to tap a handful of commercial lab companies in the U.S. to help expand and speed up distribution of its orthopoxvirus test.
The lab providers chosen included Aegis Science, Mayo Clinic Laboratories, Quest Diagnostics, Sonic Healthcare and Labcorp, all of which have begun offering the test in recent weeks. The PCR assay—which was developed in tandem with Labcorp—can detect all non-smallpox-related orthopoxviruses, including monkeypox as well as cowpox, horsepox and camelpox.