QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced
the launch of its QuantiFERON-EBV RUO (Research Use Only) assay.
Epstein-Barr virus (EBV), or human herpes virus 4, is estimated in
various epidemiological studies to be positive in more than 90% of
the world’s population and is a significant pathogen in organ
transplant recipients.
This new addition to the QuantiFERON portfolio
of assays is designed to support research into EBV infection and
EBV-related malignancies by utilizing highly specific EBV antigens
to stimulate a cell-mediated immune response, offering a dynamic
view of the host’s active immune engagement with the virus.
EBV is involved in diseases ranging from
infectious mononucleosis to EBV-related tumors and tumor-like
lesions. In organ transplant recipients, EBV is associated with
post-transplant lymphoproliferative disorder (PTLD), a potentially
fatal complication after solid organ transplantation. Over 80% of
PTLD cases in Europe and the U.S. are estimated to be
EBV-associated.[1]
Additionally, a growing body of evidence
suggests a potential connection between EBV and multiple sclerosis
(MS), a chronic disease of the central nervous system estimated to
affect more than 2.8 million people worldwide. EBV T-cell
measurement in MS might have a potential role in understanding
disease progression, treatment monitoring and developing tailored
therapeutic approaches.[2]
“The QuantiFERON-EBV RUO assay represents a
significant advancement in our understanding of the complex
relationship between EBV and the immune system,” said Jean-Pascal
Viola, Senior Vice President, Head of the Molecular Diagnostics
Business Area at QIAGEN. “This assay opens doors to innovative
research, offering insights that can revolutionize patient care by
guiding tailored treatment across various medical fields, including
oncology and autoimmune disease.”
T-cells play a crucial role in controlling and
eliminating viruses, with an effective T-cell response helping
determine the course and severity of an EBV infection. Measuring
the T-cell response to EBV can help researchers better understand
immune responses to the virus. Specifically, in transplant
patients, it has the potential to personalize immune suppressive
treatment, stratify the risk of EBV-induced disease, assist
clinicians in customizing the timing of testing and monitoring, and
evaluate the efficiency and durability of future EBV vaccines.
QuantiFERON-EBV RUO uses a combination of CD4+
and CD8+ antigens specific to EBV nuclear antigen proteins, to
stimulate lymphocytes in heparinized whole blood. This approach is
different from but complementary to traditional tests, which focus
on detecting viral DNA or antibodies produced in response to the
virus.
Growing portfolio of QuantiFERON
cell-mediated immune response tests
The new assay adds to the growing QuantiFERON
portfolio of cell-mediated immune response tests. QuantiFERON-TB
Gold Plus is the world’s leading IGRA blood test, with millions of
tuberculosis tests performed annually. QuantiFERON SARS-CoV-2
identifies immune responses to COVID-19, while QuantiFERON-CMV is
an indirect test for cytomegalovirus infections in transplant
patients. QuantiFERON Monitor evaluates nonpathogen-specific
cell-mediated immune responses in transplant patients. Furthermore,
QIAGEN and DiaSorin collaboratively developed the LIAISON
LymeDetect test, which utilizes QuantiFERON technology to detect
early Lyme Borreliosis infections. [3]
QIAGEN’s QuantiFERON technology is a unique
method for detecting cell-mediated immune responses from whole
blood samples. It works by identifying specific T-cells in
individuals with infectious agent exposure. When an
infection-specific antigen is combined with the blood, rapid
re-stimulation of antigen-specific T-cells occurs, leading to the
secretion of interferon-gamma (IFN-γ), which can be measured as a
marker of an immune response. The tests include QuantiFERON blood
collection tubes with their proprietary stimulation principle and
the QuantiFERON ELISA detection system to measure the resulting
interferon-gamma.
For more information on QIAGEN’s QuantiFERON-EBV
RUO product, visit
https://www.qiagen.com/us/products/diagnostics-and-clinical-research/transplant/quantiferon-transplant/quantiferon-ebv-bct-spp-ruo.
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) and Life Sciences (academia, pharma
R&D and industrial applications, primarily forensics). As of
June 30, 2023, QIAGEN employed more than 6,100 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
[1] Parker A, Bowles K, Bradley JA, et al. Diagnosis of
post-transplant lymphoproliferative disorder in solid organ
transplant recipients - BCSH and BTS Guidelines. Br J Haematol.
2010;149:675–692.
https://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2010.08161.x[2]
Bar-Or, Amit et al., “Epstein–Barr Virus in Multiple Sclerosis:
Theory and Emerging Immunotherapies”, Trends in Molecular Medicine,
March 2020, Published December 2019;
https://doi.org/10.1016/j.molmed.2019.11.003[3] Product
availability may differ from country to country based on
regulations and approvals.
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 Berheide
QIAGEN N.V.
+49 2103 29 11676
pr@qiagen.com
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