QIAGEN Launches Syndromic Test for QIAstat-Dx Device to Combat Global Monkeypox Health Emergency

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of the QIAstat-Dx Viral Vesicular Panel RUO, the first syndromic test to differentiate between monkeypox and five other pathogens which cause similar symptoms.

The new panel ­– currently for research use only (RUO) – comes in cartridge form to run on QIAGEN’s QIAstat-Dx automated syndromic testing devices. It tests for the two known forms of monkeypox virus (the so-called West African and Congo Basin clades), herpes simplex virus 1 (HSV1), HSV2, human herpesvirus 6 (HH6), varicella-zoster virus (VZV) and enterovirus – pathogens that all produce similar-looking vesicular lesions.

With some 3,000 QIAstat-Dx PCR devices installed in specialized laboratories around the world, QIAGEN is leveraging the value of syndromic testing proven during the pandemic to help fight the spread of monkeypox, recently declared a public health emergency by the World Health Organization (WHO) and the US government.

“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, Senior Vice President, Head of the Molecular Diagnostics Business Area at QIAGEN. “Currently the world’s only syndromic test for the pathogen, the panel will prove to be crucial for detecting and then combatting the spread of monkeypox around the globe.”

The panel’s RUO-status means it currently can only be used for the surveillance – not screening or diagnosing – of monkeypox cases. But QIAGEN is ready to make applications for clinical use should authorities in the United States and the European Union open new diagnostic pathways in light of this public-health emergency.

QIAGEN teams around the world are working with healthcare authorities to support testing for the monkeypox virus outbreak. The QIAstat syndromic testing solution adds to the broad portfolio that the company offers to address all testing needs. Alongside QIAGEN sample-technology kits, testing components and instruments that are used for instance by public health agencies for the development of their own tests, the NeuMoDx clinical PCR system allows laboratories to process self-developed tests (LDTs). A commercial single-plex assay running on this instrument is currently in development. The QIAcuity digital PCR also allows for monkeypox detection in wastewater – a surveillance method that proved its worth during the COVID-19 crisis.