- The LIAISON® LymeDetect® assay is a solution for the early
diagnosis of Lyme Borreliosis combining detection of IgG and IgM
Antibodies and cellular immunity
- The test is available in countries accepting the CE Mark and is
designed to be run on the DiaSorin LIAISON® XL and LIAISON® XS
platforms
- In clinical studies, the assay showed, within 21 days from the
first evidence of infection, a sensitivity of 74% versus that of
existing, established methods at 49%, while also demonstrating a
high diagnostic specificity of 100%
- QIAGEN is responsible for product development and
manufacturing, while DiaSorin is responsible for global
commercialization of the new solution
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) and
DiaSorin (FTSE MIB: DIA) today announced the launch of the LIAISON®
LymeDetect® Assay for markets accepting the CE Mark, as an aid to
detect early Lyme Borreliosis infection (Lyme) on LIAISON® analyzer
systems.
Lyme is a tick-borne illness caused by the Borrelia burgdorferi
bacterium species, with different types of manifestations in the
early phase: early-localized rash (the typical Erythema Migrans)
and early-disseminated forms, where people may develop a different
kind of rash, remain asymptomatic or have quite non-specific
symptoms such as fever, chills, headache, fatigue, muscle and joint
aches.
If the early infection is left untreated, Borrelia burgdorferi
might spread to joints, the heart and the nervous system becoming a
chronic illness and evolving into severe complications. Late stage
symptoms can include severe headaches and neck stiffness, facial
palsy, arthritis with severe joint pain and swelling, intermittent
pain in tendons, muscles, joints, and bones, heart palpitations or
an irregular heartbeat (Lyme carditis), inflammation of the brain
and spinal cord and pain.1 These long term effects may persist
after a successful treatment course.
Recent publications2 estimate that the total number of yearly
cases in Western Europe could be as high as 230,000.
The current diagnostic routine for early disseminated Lyme
diagnosis uses serological testing for IgG and IgM antibodies
detection (B cell response), followed by a confirmation using
Western Blot in case of positivity or equivocal results.
In the early stages of the infection, however, results can be
unsatisfactory because patients often get tested at the onset of
the disease, when visible signs of the tick bite or the presence of
the tick itself are detected, but before the appearance of
antibodies (IgG or IgM) against the pathogen. An undetected Lyme
disease presents an increased risk of developing into a severe
chronic disease. This presents a significant untapped diagnostic
need.
DiaSorin and QIAGEN have been collaborating to provide a
solution to this diagnostic gap which significantly improves the
sensitivity of testing in the early phase of Lyme borreliosis. The
new LIAISON® LymeDetect® solution combines both humoral (detection
of IgG and IgM antibodies) and cellular immunity through a specific
interferon-gamma release assay, stimulated by specific Lyme
peptides using QuantiFERON® LymeDetect® technology, providing
significantly improved sensitivity and earlier detection of the
infection.
In clinical studies, the LIAISON® LymeDetect® Assay showed,
within 21 days from the first evidence of infection, a sensitivity
of to 74% versus that of existing alternative methods (ca. 49%).
Moreover, the LIAISON® LymeDetect® Assay also demonstrated a high
diagnostic specificity of 100%.
By providing a tool which significantly increases the
sensitivity in the early stages of the disease, the LIAISON®
LymeDetect® could help physicians identify and treat the disease
earlier, minimizing the risk of late and chronic manifestation,
with benefits for patients and a significant healthcare cost
reduction, mainly due to shorter hospitalization and long-term care
for late disease treatment.
DiaSorin and QIAGEN worked together to co-develop the new
LIAISON® LymeDetect®, an innovative solution for diagnosing Lyme
disease, designed to be run on the LIAISON® XL and LIAISON® XS
platforms. Under the development agreement, DiaSorin is responsible
for commercialization of the new LIAISON® LymeDetect, while QIAGEN
and DiaSorin are jointly responsible for development and production
of the solution.
“QIAGEN believes in expanding and maximizing the value of our
QuantiFERON portfolio, led by the gold-standard QuantiFERON TB
Gold-Plus Assay that forms the foundation of our collaboration with
DiaSorin and the joint global marketing of our solution for use on
the LIAISON family of analyzers,” said Thierry Bernard, Chief
Executive Officer of QIAGEN. “The fight against Lyme disease is
increasingly critical given the risks and symptoms and estimates
that the number of ticks carrying the disease is on the rise
worldwide. For this collaboration, we are taking a new approach
with DiaSorin that builds on our unique strengths, in particular
our capabilities to develop and gain approval for novel
QuantiFERON-based tests and DiaSorin’s expertise with its current
portfolio of solutions for this disease. We are eager to see the
benefits of this partnership in improving outcomes for patients
suffering from a disease with often debilitating consequences.”
“We are very proud of this new milestone reached in partnership
with QIAGEN, because we think it is going to be a game-changer in
the Lyme disease diagnosis space and a milestone in our Value Based
Care strategy,” commented Carlo Rosa, Chief Executive Officer of
DiaSorin Group. “The collaboration between our companies leverages
on their QuantiFERON technology and our extensive installed base of
LIAISON family analyzers and is positioning us both as leaders in
the T-cell response market with a unique franchise for laboratories
looking for an efficient way to detect asymptomatic infections and
risks that cannot be detected in all situations with standard
diagnostic technologies. This new solution, together with our
already validated Lyme disease tests, will strengthen our role as a
company committed to find solutions for diagnosing a disease so
prevalent in specific regions and so difficult to detect at an
early stage that causes painful and long-lasting consequences in
the lives of affected patients.”
QIAGEN’s QuantiFERON-TB Gold Plus for latent tuberculosis is
registered in more than 75 countries in North America, Europe,
Asia, Africa and Latin America. QIAGEN’s QuantiFERON-TB Gold (QFT)
and QFT-Plus tests are the gold standard blood tests for latent TB,
with faster, less labor-intensive and more accurate insights than
the century-old tuberculin skin test. The test can be automated on
DiaSorin LIAISON® platforms. The QuantiFERON Product portfolio also
includes tests for SARS-CoV-2 T-Cell immune response, CMV and
QuantiFERON Monitor used for transplant applications. LymeDetect®
is the newest expansion to this portfolio leveraging innovative
CD4/CD8 T cell technology to enable immune response detection.
About DiaSorin
Headquartered in Italy and listed at the Italian Stock Exchange
in the FTSE MIB Index, DiaSorin is a global leader in the In Vitro
Diagnostic (IVD) field, with 26 companies, 4 branches, 5
manufacturing facilities and 5 research and development
centers.
For over 50 years, the Company has been developing, producing
and marketing reagent kits used by diagnostic laboratories
worldwide.
The extensive diagnostic testing offer, made available through
continuous investments in research, positions DiaSorin as the
player with the broadest range of specialty tests available within
the diagnostic market, and identifies the Group as the “Diagnostic
Specialist”.
More info at www.diasoringroup.com
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 December 31, 2020, QIAGEN
employed approximately 5,600 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.
Category: Corporate
1 https://www.cdc.gov/lyme/signs_symptoms/index.html 2 Source:
https://doi.org/10.1093/pubmed/fdw017
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version on businesswire.com: https://www.businesswire.com/news/home/20210420006157/en/
For DiaSorin Riccardo Fava Corporate Vice
President Communication & Investor Relations
riccardo.fava@diasorin.it Tel: +39.0161.487988
Emanuela Salvini Investor Relator Tel: +39.0161.487567
emanuela.salvini@diasorin.it
For 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
Robert Reitze, +49 2103 29 11676 e-mail: pr@QIAGEN.com
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