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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

QGEN | April 11, 2019

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

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 platforms.

“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.

QIAGEN at ECCMID 2019

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 - #P0665
Quantitative detection of HCV using the NeuMoDx Molecular System - #P0792
Performance of the NeuMoDx quantitative cytomegalovirus test on the NeuMoDx molecular system - #P0005

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.

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 (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 (SEC).

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