Qiagen joins monkeypox test-making efforts with 6-in-one assay

As the number of monkeypox cases around the world has ballooned since early May, so too has the list of diagnostic developers rapidly churning out tests for the virus.

Latest to join the likes of Labcorp, Roche, BD, Cepheid and others in that mission is Qiagen, which announced this week the launch of a monkeypox assay of its own. The test is designed to be analyzed by the company’s QIAstat-Dx PCR testing system.

Unlike many of the other recently produced monkeypox tests, Qiagen’s is syndromic, meaning it tests for multiple pathogens that may present with similar symptoms. So, in addition to detecting both the West African and Congo Basin clades of monkeypox, it also looks for herpes simplex virus 1 and 2, human herpesvirus 6, varicella-zoster virus—which can cause chickenpox and shingles—and enterovirus.

The six pathogens may be easily confused since they all produce similar vesicular lesions, which are raised, fluid-filled blisters that crop up on the skin after infection.

The QIAstat-Dx Viral Vesicular Panel is indicated for research use, making the test available to the approximately 3,000 laboratories around the world that already have QIAstat-Dx PCR analyzers installed.

Researchers in those labs will be able to use the assay only for surveillance, rather than diagnosis, Qiagen said in the release, adding that it will apply for clinical use authorization in the U.S. and Europe if regulators there “open new diagnostic pathways.”

“Monkeypox cases are soaring across the globe with many demographic groups infected. Surveillance is an essential tool in the fight against infectious diseases. QIAstat-Dx Viral Vesicular Panel in combination with the QIAstat-Dx platform will allow medical researchers to detect monkeypox with gold-standard PCR testing technology in about one hour,” said Jean-Pascal Viola, head of Qiagen’s molecular diagnostics business.

Qiagen’s tests for the system are packaged in single-use cartridges that contain all the reagents needed to prepare a sample and run the test. Once a sample has been placed inside the cartridge, it’s inserted into the analyzer, which returns results on its touchscreen and saves them to the system, from which they can be printed or exported.

The German testmaker said it’s also developing a single-plex, monkeypox-specific assay for commercial use, which will run on its NeuMoDx clinical PCR system.

As of Monday, more than 36,500 cases of monkeypox have been confirmed around the world, almost all of them in regions where the virus isn’t endemic, according to data from the U.S. Centers for Disease Control and Prevention. Nearly one-third of those cases have been found in the U.S.

The outbreak was declared a public health emergency in the U.S. at the beginning of this month, about two weeks after the World Health Organization handed down the label on a global scale.