HILDEN, Germany & GERMANTOWN, Md.– 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.
