U.S. CDC Endorses the Use of Digital PCR Technology for Wastewater Surveillance of Infectious Diseases – Including COVID-19 Outbreaks
01 Juni 2022 - 10:05PM
Business Wire
- 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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version on businesswire.com: https://www.businesswire.com/news/home/20220601006158/en/
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
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