QIAGEN’s QuantiFERON®-TB Passes Milestone of 60 Million Tests in Global Fight against Tuberculosis, Current Annual Run Rate Exceeds 12 Million Tests

New automation options highlighted for QuantiFERON®-TB
Gold Plus at ECCMID 2019 to increase efficiency and improve ease of
adoption for modern gold standard latent TB test

HILDEN, Germany & GERMANTOWN, Md. & AMSTERDAM–(BUSINESS WIRE)–lt;a href=”https://twitter.com/search?q=%24QGEN&src=ctag” target=”_blank”gt;$QGENlt;/agt;–QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced
that its modern gold standard QuantiFERON®-TB test for
detection of latent tuberculosis (TB) infections has surpassed 60
million tests administered, having impacted the lives of millions of
patients worldwide and supporting the global fight against this public
health issue.

QIAGEN is continuing to improve and innovate with new automation options
for the fourth-generation QuantiFERON®-TB Gold Plus
(QFT®-Plus) test which will continue to drive rapid
growth in the conversion of latent TB testing from the century-old
technology of tuberculin skin tests to QIAGEN’s modern, accurate and
efficient blood test.

The global fight against tuberculosis, the world’s most deadly
infectious disease, is a major focus at the 29th European Congress of
Clinical Microbiology & Infectious Diseases (ECCMID 2019), taking place
April 13-16 in Amsterdam, Netherlands. Numerous presentations will deal
with prevention, diagnosis and treatment of the disease, in its active
contagious stage or as a latent infection, in at-risk populations. Four
studies focusing specifically on applications of QFT-Plus will be
presented at ECCMID 2019.

“As the global community increasingly embraces latent TB screening and
treatment to prevent the active disease from spreading, QuantiFERON-TB
Gold Plus is the gold standard not only for accuracy but also for
cost-efficient, automated workflows. We are proud to achieve the
milestone of 60 million QuantiFERON-TB tests, but we are still in the
early days of converting from antiquated methods to modern diagnostics,”
said Peer M. Schatz, Chief Executive Officer of QIAGEN. “This is an
exciting time of innovation, commitment and progress toward the shared
goal of stopping the global epidemic of tuberculosis.”

QIAGEN continues to enhance the ease of use, efficiency and
accessibility of QuantiFERON-TB tests:

  • A read-out kit for QuantiFERON-TB Gold Plus, which was CE-IVD marked
    in 2018, is rolling out in Europe and other markets as part of
    DiaSorin’s broad menu of tests for its LIAISON chemiluminescent
    immunoassay platforms. This efficient automated solution for analysis
    of QFT-Plus is expected to be available in 2019 in the United States
    and in 2020 in China. DiaSorin has placed more than 7,000 LIAISON
    instruments in hospitals and laboratories around the world.
  • QIAGEN is partnering with two leaders in liquid handling solutions to
    provide options for automated aliquoting of samples from the single
    tube option to the QuantiFERON-TB Gold Plus Tubes for analysis with
    the QFT-Plus assay, for those customers who choose to implement a
    single tube collection process. The collaborations integrate the
    Hamilton Robotics Microlab® STAR™ automated liquid handling
    workstation into the QFT-Plus assay workflow, or the Tecan Fluent® Laboratory
    Automation workstation to automate the manual step of aliquoting of
    samples from a single collection device such as Lithium Heparin blood
    collection tube into the QuantiFERON-TB Gold Plus workflow.
  • In partnership with Ellume, a digital diagnostics developer, QIAGEN is
    developing QuantiFERON®-TB Access (QFT® Access)
    as a novel workflow dedicated to the needs of low-resource regions
    with a high disease burden of TB. The global community has an unmet
    need for a low complexity, highly accurate test for latent TB designed
    with a focus on cost efficiency and ease of use that brings the best
    in class QuantiFERON technology to these settings. Clinical trials for
    QFT Access are planned for this year, and commercialization is
    expected to begin in 2020.


Exhibition booth No. 1.20 at ECCMID 2019 will feature demonstrations of
QIAGEN’s Sample to Insight solutions for infectious diseases, including
QuantiFERON-TB Gold Plus and the company’s QIAstat-Dx, NeuMoDx 288 and
96, and QIAsymphony automation systems. To learn more about QIAGEN’s
presence at ECCMID, please visit http://eccmid.qiagen.com
or follow the Twitter handle @QIAGEN
during the conference.

QuantiFERON-TB Gold Plus combines a flexible new blood collection
workflow with innovative CD4/CD8 T cell technology to enable the most
comprehensive TB immune response detection available. Now marketed in
more than 75 countries, QFT-Plus has been adopted by many organizations
such as the International Organization for Migration and the
International Panel Physicians Association. More than 20 peer-reviewed
publications to date have supported the performance of QFT-Plus, and
studies underway in 22 countries involve more than 30,000 patients. For
more information, please visit www.quantiferon.com.

Tuberculosis is a contagious bacterial infection spread primarily by
coughing of patients with the active pulmonary form of the disease. In
2017, the World Health Organization (WHO) estimates, there were 10
million new cases of active TB worldwide and 1.6 million deaths from TB.
In latent tuberculosis infection (LTBI), the bacterium infects a person
but produces no symptoms unless it progresses to the active disease. On
a global basis, approximately one out of four people are estimated to
have latent TB infection, and about 5-10% of those individuals, if
untreated, will progress to active tuberculosis at some point in their


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, 2018, QIAGEN employed about 5,000 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, launches,
regulatory submissions, collaborations, markets, strategy, taxes or
operating results, including without limitation its expected sales,
adjusted net sales and adjusted diluted earnings per share 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; 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 (SEC).




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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