QIAGEN’s New Generation of QuantiFERON TB Test Gains Chinese Approval and Renewed WHO Recommendation
February 07 2022 - 1:30AM
Business Wire
- QuantiFERON-TB Gold Plus (QFT-Plus), the fourth generation of
the modern gold standard for TB detection, receives Chinese NMPA
approval as test for active tuberculosis detection
- World Health Organization (WHO) endorses QFT-Plus as
alternative IGRA test for diagnosis of TB infection, recommends new
QIAreach QFT for research use in epidemiological settings
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today
announced that its QuantiFERON tuberculosis (TB) testing solution
has gained additional momentum with the approval of the fourth
generation of this modern gold standard test in China and a new
endorsement from the World Health Organization (WHO).
Among the recent developments:
- China’s National Medical Products Administration (NMPA) has
approved QuantiFERON-TB Gold Plus (QFT-Plus) for TB diagnosis,
including active TB infections. This builds on the regulatory
approvals for QFT-Plus for latent TB diagnosis in the U.S. and
other countries around the world, including CE-IVD marking.
QFT-Plus is an important improvement over the previous version of
QuantiFERON that was approved and used in China, offering even more
accurate detection of infection, including in immunocompromised
people. In China, all available IGRA tests including QFT-Plus are
licensed to rule out active TB – other countries also approve these
tests to detect the latent form of the TB disease (LTBI), in which
people are infected, and have the potential to develop active
disease. Since 2013, more than 1.5 million people in China have
been tested for active TB infection using the proprietary
QuantiFERON technology.
- The WHO has renewed its recommendation that blood-based
Interferon-Gamma Release Assays (IGRA) are an alternative for the
diagnosis of TB infection, in addition to the Tuberculin Skin Test
(TST). In its latest policy statement, the WHO also took the first
step towards endorsing the use of QIAGEN’s QIAreach QuantiFERON-TB
(QIAreach QFT) - a portable, battery-operated test for TB detection
especially designed for low-resource, high-burden regions - by
recommending its use for additional research in more geographical
and epidemiological settings. QIAreach QFT was launched in late
2021 and was recently 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).
“The approval of the latest version of QuantiFERON TB-Gold Plus
in China strengthens the global coverage that QIAGEN can offer in
the fight against TB,” said Jean-Pascal Viola, Senior Vice
President of the Business Area Molecular Diagnostics at QIAGEN.
“The new WHO recommendation for IGRA tests also confirms the
clinical performance and utility of IGRAs, and in particular the
value of QFT-Plus as the modern gold standard for blood-based TB
detection. Additionally, we are pleased that the WHO recognizes the
potential of QIAreach QFT to become a crucial element in TB
detection strategies and our commitment to leave no country behind
in this fight.”
"QuantiFERON TB-Gold Plus is much easier for our laboratory
technicians to use than other tests – it doesn’t require
complicated lab technology and is easily scalable for the kind of
high-throughput testing we need,” said Dr. Gao Lei, Professor,
Institute of Pathogen Biology at the Chinese Academy of Medical
Sciences. "The world needs new technologies and methods to contest
TB – and QIAGEN’s IGRA technology is playing a crucial role
here.”
QuantiFERON-TB Gold Plus and QIAreach QFT use blood samples to
test for interferon-gamma proteins released from T-cells that have
had contact with TB bacteria. They are the fastest and most
convenient IGRA tests, as they do not require the isolation of
white blood cells. Single-visit IGRA tests are a quantum leap from
the use of Tuberculin Skin Test, which requires two visits to
health professionals and a visual inspection to detect an
infection.
Over two billion people worldwide are estimated to have LTBI.
Clinical studies have shown that approximately 10% of these people
– who are neither ill nor show symptoms – will develop active TB in
their lifetimes. The active form of the disease is infectious, and
particularly dangerous for people with weakened immune systems as a
result of the use of immunosuppressive medications or comorbidities
such as diabetes, HIV and other conditions. The active form of
tuberculosis most often affects the lungs and can spread easily.
While a healthy immune system can successfully fight TB, the
disease is often fatal if left untreated – especially for people
with weakened immune systems. In 2020, about 1.5 million people
died worldwide from TB, according to the WHO.
For more information, please visit www.qiagen.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
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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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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