U.S. CDC Endorses the Use of Digital PCR Technology for Wastewater Surveillance of Infectious Diseases – Including COVID-19 Outbreaks

• U.S. public health agency validated digital PCR technologies – including QIAcuity – as the way to reliably detect multiple disease targets in wastewater samples
• QIAcuity previously awarded U.S. contract for public health labs utilization in 70% of all U.S. states
• QIAGEN offers broad portfolio to address demands for testing beyond pandemic

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that it welcomed an endorsement from the National Wastewater Surveillance System (NWSS) of the U.S. Centers for Disease Control and Prevention (CDC) and their validation and approval for the use of two digital PCR systems – including the QIAcuity digital PCR system – for wastewater surveillance of 30 pathogens, including the SARS-CoV-2 virus.

The decision of the U.S. national public health agency marks a step away from the traditional quantitative PCR (qPCR) approach to the novel digital PCR technology as a more reliable detection method. Digital PCR (dPCR) can quantify the tiniest traces of DNA and RNA – and recently also the proteins encoded by these genetic materials – to test for infectious diseases caused by viruses and bacteria, and other disorders like cancer mutations. The CDC will now develop the wastewater pathogen assays and provide them to public health labs to run on either system, thereby converting their current qPCR assays to dPCR testing.

The decision by the NWSS also means that the CDC will only accept wastewater surveillance data collected with QIAcuity or the other approved digital PCR instrument, and that related public funding through the CDC’s Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) Cooperative Agreement will be limited to the use of one of these two platforms. The ELC supports state, local, and regional health departments in the detection, prevention, and response to emerging infectious diseases.

The approval comes after QIAGEN previously completed a U.S. government contract to equip public health laboratories across the country with QIAcuity dPCR devices, initially to monitor the spread of COVID-19 by testing wastewater. More than 70% of U.S. states now have at least one public or privately-owned laboratory that can monitor wastewater with QIAcuity, a system that has set new standards by delivering results in two hours.

Wastewater surveillance has a broad range of applications beyond COVID-19 testing and can be used to protect communities from a variety of infectious diseases, such as the detection of antimicrobial resistant "superbugs" and food-borne diseases such as E. coli or Listeria.

“The CDC’s decision is a testament to the quality and robustness of our QIAcuity dPCR system and is further proof of the reputation it is gaining among public health experts in- and outside the United States,” said Thomas Schweins, Ph.D., Senior Vice President, Life Science Business Area at QIAGEN. “The CDC protocol covers a multitude of targets beyond COVID-19, which shows that our portfolio – including QIAcuity as one of our five growth pillars – has a huge relevance for many other infectious diseases.”

QIAGEN is currently expanding the QIAcuity menu into new research applications, such as proteomics, and also expansion into clinical healthcare. The analysis of the interactions between different proteins and between proteins and genetic material is meant to complement genomic analysis and give more comprehensive pictures of diseases.

Digital PCR is more accurate and sensitive than traditional qPCR as it more precisely quantifies nucleic acids and target sequences of DNA and RNA. The technology’s success in wastewater testing shows its potential in disease surveillance more generally. Surveillance allows public authorities to collect data from broad sweeps of the population and give early warnings about outbreaks of infectious diseases.

More information about QIAGEN solutions for wastewater testing can be found here.

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), Applied Testing (primarily forensics), Pharma (pharma and biotech companies) and Academia (life sciences research). As of March 31, 2022, QIAGEN employed more than 6,000 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

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