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

Rhea-AI Summary

QIAGEN has launched the QIAstat-Dx Viral Vesicular Panel RUO, a groundbreaking test to differentiate monkeypox from five other pathogens. This test, utilizing gold-standard PCR technology, is vital for global surveillance as monkeypox cases increase. Currently available for research use only, the panel will support healthcare authorities in the fight against infectious diseases. With over 3,000 QIAstat-Dx devices deployed worldwide, QIAGEN aims to enhance testing capabilities significantly as they prepare for potential clinical applications pending regulatory developments.

Positive

• Launch of QIAstat-Dx Viral Vesicular Panel RUO to differentiate monkeypox from other pathogens.
• Utilization of gold-standard PCR technology for accurate testing.
• More than 3,000 QIAstat-Dx devices installed globally, enhancing testing accessibility.
• Potential for future clinical applications as regulatory pathways open.

Negative

• Currently only for research use; not available for clinical screening or diagnosis.
• Dependence on regulatory approvals to transition from research use to clinical applications.

• QIAstat-Dx Viral Vesicular Panel tests for six pathogens that produce similar symptoms

• Panel boosts global research and surveillance of monkeypox using gold-standard PCR technology

• QIAGEN offers broad testing portfolio to support healthcare authorities around the globe, as it did with SARS-CoV-2

HILDEN, Germany & GERMANTOWN, Md,--(BUSINESS WIRE)-- 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.

The concept of syndromic testing has shown its value during the pandemic, when QIAGEN launched the QIAstat-Dx Respiratory SARS-CoV-2 panel to differentiate between up to 23 viral and bacterial targets for common pathogens causing respiratory tract infections. The company also introduced the high-throughput QIAstat-Dx Rise device that processes up 160 tests per day. QIAGEN has extended syndromic testing to other areas, including gastrointestinal conditions and meningitis.

To learn more about the QIAstat-Dx Viral Vesicular Panel and the QIAstat-Dx range, please visit: https://www.qiagen.com/applications/syndromic-testing.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of June 30, 2022, QIAGEN employed more than 6,100 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Forward-Looking Statement

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN's products, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN's products (including fluctuations due to general economic conditions, the level and timing of customers' funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN's products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors' products; market acceptance of QIAGEN's new products and the integration of acquired technologies and businesses. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission (SEC).

Source: QIAGEN N.V.
Category: Corporate

View source version on businesswire.com: https://www.businesswire.com/news/home/20220815005598/en/

Contacts QIAGEN:

Investor Relations

John Gilardi +49 2103 29 11711

Phoebe Loh +49 2103 29 11457

e-mail: ir@QIAGEN.com

Public Relations

Thomas Theuringer

+49 2103 29 11826

e-mail: pr@QIAGEN.com

Source: QIAGEN N.V.

FAQ

What is the QIAstat-Dx Viral Vesicular Panel by QIAGEN?

The QIAstat-Dx Viral Vesicular Panel is a new syndromic test that differentiates monkeypox from five other pathogens causing similar symptoms, leveraging PCR technology.

How does the QIAstat-Dx Viral Vesicular Panel impact monkeypox surveillance?

This panel enhances global surveillance efforts for monkeypox amid rising cases, allowing quicker and more accurate detection.

When was the QIAstat-Dx Viral Vesicular Panel launched?

The QIAstat-Dx Viral Vesicular Panel was announced by QIAGEN on August 15, 2022.

What pathogens can the QIAstat-Dx Viral Vesicular Panel identify?

The panel tests for monkeypox, herpes simplex virus 1 and 2, human herpesvirus 6, varicella-zoster virus, and enterovirus.

What is the current status of the QIAstat-Dx Viral Vesicular Panel?

The panel is currently for research use only and is not yet approved for clinical diagnosis.