QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) welcomes the
publication of a new, systematic review highlighting the unique
value of its proprietary tuberculosis (TB) testing technology. The
study highlights QIAGEN’s continued leadership in TB infection
screening, centered on QuantiFERON-TB Gold Plus test, an
interferon-gamma release assay (IGRA). The test is unique to the
market in featuring two primary blood collection tubes – TB1 and
TB2 – enabling detection of responsive CD4 T-cells in TB1, and
additionally, CD8 T-cell responses in TB2.
The meta-analysis on QuantiFERON testing was
conducted by Universitas Padjadjaran, Indonesia, and published in
Clinical Chemistry and Laboratory Medicine (CCLM)[1]. The
systematic review, based on 17 studies and including 4,050
subjects, showed a higher level of interferon-gamma (IFN-γ)
production in the QuantiFERON-TB Gold Plus TB2 tube than in the TB1
tube, confirming the important role of CD8 T-cells for a broad
immune assessment of TB infection.
Subgroup analysis in specific populations
revealed that the difference of IFN-γ production between the TB2
and TB1 tubes was significantly higher in active TB disease
subjects than in those with latent TB. The ability to differentiate
active TB disease from latent infection has long been sought by the
medical community to help stratify patient risk. This result likely
reflects a significant CD8 T-cell response in active TB subjects
and may be related to the increased tuberculosis bacterial load in
these individuals.
The study also highlighted the potential benefit
of the TB2 tube for CD8 detection in certain high-risk populations,
such as immunocompromised patients, and especially those having CD4
T-cell deficiency. It provided additional insights into the medical
relevance for detection of both CD4 and CD8 T-cell responses in the
context of diagnosis of TB infection (including disease), a feature
unique to the QuantiFERON-TB Gold Plus assays.
“Identifying TB infection in high-risk
individuals is critical to preventing the spread of TB. It plays a
vital role in achieving the World Health Organization's ambitious
EndTB strategy goals, particularly in reducing TB-related deaths by
90% by 2030, compared to 2015 levels,” said Dr. Davide Manissero,
M.D., Chief Medical Officer of QIAGEN. “The results of this large
systematic review warrant further exploration of the role of
patient stratification that QuantiFERON TB testing could offer. It
also validates our broader strategy of continual investment and
improvement of our diagnostic products with the aim to bring
increased value to patients and to address the needs of the medical
community.”
Tuberculosis is a contagious bacterial infection
spread primarily by coughing of patients with the active pulmonary
form of the disease. The World Health Organization (WHO) estimated
that there were more than 10 million new cases of active TB
worldwide and 1.6 million deaths from TB in 2021. Screening of
high-risk individuals and treatment for TB infection 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.
QuantiFERON-TB Gold Plus is the world’s leading
IGRA blood test, with millions of tests performed annually. It has
established itself as a superior alternative to the dated TB skin
test (TST), which is less effective in identifying TB infection in
people who have received BCG vaccination, which is common for
patients from high-TB-burden countries, and in patients who may be
unlikely to return for TST interpretation. QuantiFERON-TB Gold Plus
has helped patients and providers globally by reducing the number
of visits to a single blood draw with a faster turnaround time.
QuantiFERON-TB Gold Plus sets itself apart from
other IGRA tests with a streamlined workflow and the use of whole
blood samples, not purified lymphocytes. International guidance
from the CDC and the WHO support the use of blood tests like
QuantiFERON-TB Gold Plus in all settings as part of the fight to
end the global TB epidemic.
More information about TB testing and
QuantiFERON-TB Gold Plus is available at
https://www.qiagen.com/End-TB.
[1] Darmawan, Guntur et al: "Comparison of interferon-gamma
production between TB1 and TB2 tubes of QuantiFERON-TB Gold Plus: a
meta-analysis" Clinical Chemistry and Laboratory Medicine (CCLM),
2023. https://doi.org/10.1515/cclm-2023-0293
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, 2023, QIAGEN
employed more than 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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