QIAGEN Expands QuantiFERON Portfolio in the Fight Against TB
January 06 2022 - 4:05PM
Business Wire
- QuantiFERON franchise benefits from new applications, products
and automation options, building on strengths in tuberculosis
detection while addressing new disease targets
- QuantiFERON SARS-CoV-2 assay launched in December 2021 now
CE-marked for clinical use measuring SARS-CoV-2 T-cell
responses
- QuantiFERON-TB Gold Plus assay for TB detection set to benefit
from three additional U.S. patient groups: Individuals with
weakened immune systems, pregnant women and children
- QIAreach QuantiFERON-TB set for commercialization in 2022,
designed specifically to improve TB detection in high burden, low
resource countries
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today
announced important expansion initiatives for its QuantiFERON
franchise, building on its status as the gold standard for
detection of tuberculosis, while developing new applications for
this technology designed to detect potentially deadly latent
diseases.
The new initiatives are expected to help drive further growth of
the QuantiFERON franchise. A quantum leap from the traditional TB
skin test, QuantiFERON-TB uses blood samples to test for
interferon-gamma that is released from T-cells that have come into
contact with TB bacteria.
“QuantiFERON is gaining further traction and is set to continue
to make an impact on improving outcomes for people around the
world, first through its proven gold standard status for detection
of TB, while also benefiting from new applications, in particular
in the global fight against COVID-19,” said Jenny Howard, Vice
President, Head of the Global Immune Response franchise at QIAGEN.
“The recent developments add a series of new applications, products
and automation options that are broadening its reach. We are
determined to further expand the range of applications for our
immune response technology in the coming years.”
Among recent developments:
- QIAGEN is experiencing strong customer interest in the
QuantiFERON SARS-CoV-2 assay, which was launched in December 2021
and has now received a European CE mark. This test measures T-cell
responses to SARS-CoV-2 and aids in the assessment of immunity in
individuals who have received COVID-19 vaccination. T-cell response
to SARS-CoV-2 decline more slowly than antibody responses and may
indicate how severe the course of an illness triggered by
SARS-CoV-2 will be in infected patients. The QuantiFERON SARS-CoV-2
assay detects CD4+ and CD8+ T-cell responses, which enables a more
comprehensive assessment of immunity generated by COVID-19
vaccines, including clinically vulnerable individuals.
- Based on a review of extensive studies, the range of target
groups that can be tested with the blood-based QuantiFERON-TB Gold
assay for detection of TB has been expanded by the U.S. Food and
Drug Administration (FDA) to include individuals with weakened
immune systems, pregnant women and children, and also following
changes to U.S. CDC (Centers for Disease Control) guidelines.
- The battery-operated QIAreach QuantiFERON-TB test (QIAreach
QFT), which was specifically designed for use in the fight against
TB in low resource, high burden countries, has been approved by the
Global Fund’s Expert Review Panel Diagnostics (ERPD). This approval
means QIAreach QFT may now be procured by public health programs
and institutions in more than 100 countries that qualify for Global
Fund and/or UNITAID resources, as well as made available through
the Stop TB Partnership’s Global Drug Facility (GDF). This
development comes after launch in the fourth quarter of 2021, and
opens an important new channel given that the GDF is the largest
provider of TB drugs and diagnostics to the public sector. QIAreach
QFT offers digital detection of TB infection with an end-to-end
workflow that is simple and cost efficient, and increases access to
reliable Interferon Gamma Release Assay (IGRA) testing. QIAGEN will
focus on emerging market regions where access to laboratory
infrastructure and resources for testing are limited. QIAreach
QuantiFERON-TB was developed in collaboration with Ellume.
For more information, please visit http://www.qiagen.com and
https://www.quantiferon.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),
Applied Testing (primarily forensics), Pharma (pharma and biotech
companies) and Academia (life sciences research). As of December
31, 2021, 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).
Category: Corporate
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version on businesswire.com: https://www.businesswire.com/news/home/20220106005851/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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