QIAGEN and NeuMoDx expand assay menu for their next generation of fully integrated PCR systems for clinical laboratories in Europe and also announce availability of NeuMoDx 96 version

NeuMoDx plans to deliver 11 CE-IVD assays to QIAGEN by the end of
2019 on NeuMoDx System as part of aggressive menu expansion plans,
including blood-borne viruses, women’s health and transplantation assays

HILDEN, Germany & ANN ARBOR, Mich.–(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) and NeuMoDx
Molecular, Inc. today announced an expansion of the content menu for the
NeuMoDx™ 96 and 288 Molecular Systems, as well as the commercial
availability of the NeuMoDx 96 mid-throughput version of this family of
fully integrated PCR-based systems after the initial launch of the
NeuMoDx 288 high-throughput version in early 2019.

The following tests are now available as CE-IVD versions on NeuMoDx 96
and 288:

  • CT/NG – Chlamydia trachomatis and Neisseria gonorrhoeae,
    widespread sexually transmitted infections
  • GBS – Group B Streptococcus, a leading cause of
    life-threatening infections in newborns
  • HCV Quant– Hepatitis C virus, a blood-borne virus that can produce
    chronic liver infection, even death
  • HBV Quant– Hepatitis B virus, which can manifest as long-term chronic
    liver infection or acute illness

The following selected tests are planned for launch in Europe by the end
of 2019:

  • HIV Quant– human immunodeficiency virus, spread via body fluids and
    attacking the immune system
  • HPV – a PCR-based version of a test for the Human Papilloma Virus,
    considered the cause of cervical cancer in women
  • Influenza A / B and respiratory syncytial virus (RSV) – common
    respiratory viruses that can be serious, especially for infants and
    older adults
  • CMV Quant– Cytomegalovirus, a serious threat for babies or adults with
    weakened immune systems
  • EBV Quant– Epstein-Barr virus, which can cause infectious
    mononucleosis and other illnesses
  • GAS – Group A Streptococcus, the cause of strep throat, scarlet
    fever and other infections
  • TV/MG – Trichomonas vaginalis / Mycoplasma Genitalium,
    sexually transmitted infections

Clinical laboratories in Europe can now simultaneously run molecular
diagnostic tests for four different viral and bacterial pathogens, as
well as laboratory-developed tests (LDTs), on the random-access NeuMoDx

“NeuMoDx is aggressively ramping up the test menu for the NeuMoDx
platforms to help clinical laboratories process increasing test volumes
and deliver more rapid insights on a broad range of diseases. These new
assays offer customers in Europe an expanding menu of infectious
diseases, and we intend to continue rolling out new tests from a deep
pipeline for a variety of diseases,” said Thierry Bernard, Senior Vice
President and Head of QIAGEN’s Molecular Diagnostics Business Area. “The
NeuMoDx systems are disruptive next-generation solutions for clinical
laboratories that process molecular diagnostic tests, including full
automation, scalability, and cost efficiency. Customer feedback from
first installations has already highlighted the incredible ease of use
and faster time to result for DNA and RNA testing.”

“The launch of the important blood-borne virus tests for hepatitis C
(HCV) and hepatitis B (HBV) for our revolutionary NeuMoDx Molecular
Systems will deliver real benefits for clinical laboratories and the
patients they serve. Our highly sensitive, accurate molecular assays
address a wide range of pathogens and are addressing major needs for
clinical testing in infectious diseases,” said Jeff Williams, Chairman
and Chief Executive Officer of NeuMoDx Molecular, Inc., which developed
the systems and partnered with QIAGEN for commercialization outside the
United States.

Among the benefits offered by the NeuMoDx systems:

  • Fully integrated operation: These Sample to Insight automation
    solutions perform every step for PCR-based analysis and diagnosis,
    from sample extraction through detection and results reporting.
  • Rapid insights for clinicians: The NeuMoDx 288 and 96 systems
    offer turnaround times as low as 40 minutes, compared to more than
    three hours for other systems. Laboratories can report results quickly
    and comprehensively, enabling faster treatment decisions and better
    patient outcomes.
  • Broad content menu: The NeuMoDx systems offer a growing menu of
    relevant in vitro diagnostic (IVD) tests using dry reagents with long,
    room temperature shelf life, long in-use life, and unitized reactions
    to essentially eliminate reagent waste, as well as the ability to
    process both commercial and laboratory-developed tests (LDTs) for
    infectious diseases.
  • True random access: Both NeuMoDx platforms allow continuous
    loading of specimens for the first time in an integrated system. The
    broad menu and the market-leading ease of use for laboratory-developed
    tests will allow labs to consolidate all their testing needs.


The QIAGEN Portfolio is referenced in over 30 abstracts and
presentations at ECCMID. For NeuMoDx alone, the highlights include:

  • Evaluation of quantitative EBV and BKV laboratory developed test
    implementation on the NeuMoDx 288 molecular system
  • Quantitative detection of HCV using the NeuMoDx Molecular System
  • Performance of the NeuMoDx quantitative cytomegalovirus test on the
    NeuMoDx molecular system –

Exhibition booth No. 1.20 at the 29th European Congress of Clinical
Microbiology & Infectious Diseases (ECCMID 2019), taking place April
13-16 in Amsterdam, Netherlands will feature demonstrations of QIAGEN’s
Sample to Insight solutions for infectious diseases, including workflow
for the 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.

Additionally, QIAGEN will host a symposium, “Diagnosis is in the details
– how to improve patient outcomes in multiple clinical settings with
rapid, easy-to-use syndromic testing utilizing real-time PCR and Ct
values.,” at 4:00 p.m. Monday April 15 in Hall M – Forum Auditorium.
Speakers include Dr. Glen Hansen of the University of Minnesota, Dr.
Jordi Vila of Barcelona Hospital, Dr. Carmen Muñoz-Almagro of Barcelona
Hospital Sant Joan de Déu, and Tanja Rockenbach of London’s Great Ormond
Street Hospital for Children.

About NeuMoDx

NeuMoDx Molecular, based in Ann Arbor, Michigan, designs and develops
revolutionary molecular diagnostic solutions for hospital and clinical
reference laboratories. Its patented platforms offer market-leading ease
of use, true continuous random-access, and rapid turnaround time while
achieving optimal operational and clinical performance for our customers
and the patients they serve. For more information visit www.neumodx.com.


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 (forensics, veterinary testing and food
safety), Pharma (pharma and biotech companies) and Academia (life
sciences research). As of December 31, 2018, QIAGEN employed
approximately 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,
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



Investor Relations
John Gilardi
2103 29 11711
Phoebe Loh
+49 2103 29 11457
e-mail: ir@QIAGEN.com

Public Relations
Thomas Theuringer
+49 2103 29 11826
+49 2103 29 11676
e-mail: pr@QIAGEN.com


Thank you for donating to DutchNews.nl.

We could not provide the Dutch News service, and keep it free of charge, without the generous support of our readers. Your donations allow us to report on issues you tell us matter, and provide you with a summary of the most important Dutch news each day.

Make a donation