QIAGEN and NeuMoDx Expand Assay Menu for their Next Generation of Fully Integrated PCR Systems for Clinical Laboratories in Europe

QIAGEN N.V. 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.