QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today
that it welcomed the U.S. Preventive Services Task Force (USPSTF)
reaffirming a previously issued recommendation for latent
tuberculosis infection (LTBI) screening by primary care physicians
in populations at increased risk.
The USPSTF issued a final report on May 2 to
continue the “B” recommendation for screening of these populations,
building on the previous recommendation issued in 2016 by the
independent volunteer panel of experts in prevention and
evidence-based medicine.
This reaffirmation helps ensure that insured
patients in the U.S. from risk groups for TB infection continue to
have access to screening with no out-of-pocket costs to them, as
the Affordable Care Act requires that insurers provide preventive
services with an “A” or “B” recommendation at no cost.
The USPSTF recommendations referred to
QuantiFERON-TB Gold Plus (QFT-Plus) from QIAGEN as reliable in
screening. It also suggested that interferon gamma release assays
(IGRAs) like QFT-Plus may have advantages in certain patient
populations over the tuberculin skin test (TST) in a wider group of
people at risk for latent TB infection. This is in line with
guidelines from the U.S. Centers for Disease Control.
“It is important to recognize that TB is a
preventable disease that still claims too many lives every year and
remains a persistent public health issue in the U.S.,” said Jenny
Howard, Vice President, Head of the Immune Response Franchise at
QIAGEN. “We welcome this updated recommendation from the USPSTF as
an important step in the fight against TB. Stepping up screening is
increasingly critical to achieve the ambitious ‘End TB Strategy’
goals, especially in light of the setbacks in testing during the
COVID-19 pandemic.”
QuantiFERON-TB Gold Plus is the world’s leading
IGRA blood test, with millions of tests performed annually. It has
benefited patients and providers by reducing the number of visits
to a single blood draw with a faster turnaround time.
QuantiFERON-TB Gold Plus has established itself as a superior
alternative to the TST, which, as the USPSTF guidance highlights,
is less effective in identifying TB infection in people who have
received BCG vaccination, which are commonly used in patients from
high TB burden countries, and in patients who may be unlikely to
return for TST interpretation.
QuantiFERON-TB Gold Plus sets itself apart from
other IGRA tests with streamlined workflow and using whole blood
samples, not purified lymphocytes. Manual and automated solutions
are available to accommodate laboratories from low to high
throughput needs. QuantiFERON-TB Gold Plus has consistently shown a
very high specificity, providing confidence that it is detecting
those truly infected and not missing TB infection cases. This
ongoing recommendation from the USPSTF supports the continued use
of QuantiFERON-TB Gold Plus as part of the global fight against
TB.
Tuberculosis is a contagious bacterial infection
spread primarily by coughing of patients with the active pulmonary
form of the disease. In 2020, the World Health Organization (WHO)
estimated that there were 10 million new cases of active TB
worldwide and 1.5 million deaths from TB.
In the case of latent tuberculosis infection,
the bacterium infects a person but produces no symptoms unless it
progresses to the active disease.
On a global basis, approximately one out of four
people are estimated to have latent TB infection, and about 5-10%
of those individuals, if untreated, may progress to active
tuberculosis at some point. Risk of progression to active TB is
much higher in people with immune system impairment.
Screening of high-risk individuals and treatment
for LTBI plays an important role in TB control efforts in the U.S.
and many European countries, as well as in other developed and
emerging markets around the world.
To learn more about QFT and QFT-Plus, please
visit http://www.qiagen.com/applications/tb-management.
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 December 31, 2022, QIAGEN
employed approximately 6,200 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, including those
products used in the response to the COVID-19 pandemic, timing for
launch and development, marketing and/or regulatory approvals,
financial and operational outlook, growth and expansion,
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; actions of governments, global or
regional economic developments, weather or transportation delays,
natural disasters, political or public health crises, including the
breadth and duration of the COVID-19 pandemic and its impact on the
demand for our products and other aspects of our business, or other
force majeure events; as well as the possibility that expected
benefits related to recent or pending acquisitions may not
materialize as expected; and the other factors discussed under the
heading “Risk Factors” contained in Item 3 of our most recent
Annual Report on Form 20-F. 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.
Source: QIAGEN N.V.Category: Corporate
John Gilardi
QIAGEN N.V.
+49 2103 29 11711
ir@qiagen.com
Phoebe Loh
QIAGEN N.V.
+49 2103 29 11457
ir@qiagen.com
Thomas Theuringer
QIAGEN N.V.
+49 2103 29 11826
pr@qiagen.com
Daniela Eltrop
QIAGEN N.V.
+49 2103 29 11676
pr@qiagen.com
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