QIAGEN, NeuMoDx Partner to Offer Next-Generation Systems for Molecular Diagnostic Testing

QIAGEN N.V. and NeuMoDx Molecular Inc. have announced a strategic partnership to commercialize two new fully integrated systems for automation of PCR (polymerase chain reaction) testing. These next-generation systems are specifically designed to help clinical molecular diagnostic laboratories process increasing test volumes and deliver more rapid insights on a broad range of diseases.
 
Under the agreement, QIAGEN will initially distribute the NeuMoDx 288 (high-throughput version) and NeuMoDx 96 (mid-throughput version) in Europe and other major markets worldwide outside of the United States. NeuMoDx will cover the United States directly. The two companies have also entered into a merger agreement under which QIAGEN can acquire all NeuMoDx shares not currently owned by QIAGEN at a predetermined price of approximately $234 million (QIAGEN currently owns about 19.9 percent of NeuMoDx), subject to the achievement of certain regulatory and operational milestones.
 
QIAGEN intends to begin commercialization of the NeuMoDx systems with an initial assay menu based on the first two CE-IVD marked assays for Group B Streptococcus(GBS) and Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) infections. The NeuMoDx systems offer a growing menu of relevant in-vitro diagnostic (IVD) tests and the ability to process both commercial and laboratory-developed tests (LDTs) in the most flexible and efficient manner. LDTs, which account for an important number of test requests and volumes, are IVD tests designed by clinical labs for their own use.
 
“Molecular diagnostic labs are demanding a true next generation of solutions for molecular diagnostic testing with features such as full automation, fast turnaround time, scalability, cost efficiency and ease of use,” said Peer M. Schatz, CEO of QIAGEN N.V. “The NeuMoDx approach delivers on this promise to customers with simpler and much faster workflows on more compact and versatile systems. It brings the simplicity of established clinical chemistry automation to molecular diagnostics along with rapid turnaround time in about an hour and promises massive sample processing capacity and a broad menu of tests. Together with QIAsymphony, QIAstat-Dx and GeneReader, the addition of NeuMoDx will enable QIAGEN to offer complementary systems that create an unparalleled portfolio of platforms for molecular diagnostics labs worldwide— addressing all key segments. We are determined to expand on our leadership position by offering solutions for use in every molecular diagnostics laboratory worldwide.”
 
“We are excited about joining forces with QIAGEN to take NeuMoDx to the next level on a global basis. These new solutions for molecular diagnostics, along with a rich menu of tests under development, will deliver real benefits to central laboratories, hospitals and the patients they serve,” said Jeff Williams, chairman and CEO of NeuMoDx Molecular. “This agreement with QIAGEN is an important recognition of the excellence of our NeuMoDx team, our achievements in developing the platform and the work we continue to do. We begin this collaboration by launching the NeuMoDx systems and initial assays, and the relationship will deepen as we achieve additional development and commercialization milestones.”
 
The NeuMoDx systems possess many key features that differentiate them from other laboratory-based PCR diagnostics systems. Most importantly, the NeuMoDx systems have the distinction of fully integrated operation, including performing every step from sample extraction through detection and results reporting. The addition of these systems strengthens QIAGEN’s portfolio of molecular testing platforms to address laboratory needs in almost any setting for molecular diagnostics.
 

• Rapid access to insights: The NeuMoDx 288 and 96 systems offer a combination of speed, flexibility, throughput and ease of use. Melding high-throughput specimen processing capabilities with the industry’s fastest fully automated turnaround time produces insights in about one hour compared to competing systems requiring more than three hours. With up to 42 patient specimens processed per hour, the relatively compact NeuMoDx 288 offers higher levels of throughput than almost any other system. Laboratories’ ability to report results back to ordering physicians more comprehensively and in a much shorter period of time will be greatly enhanced, thereby enabling faster treatment decisions and better outcomes. The speed of the NeuMoDx systems is derived from many fundamental innovations such as patented extraction technologies, advanced microfluidics and silicon technology-based thermal cycling. Both systems can be fully integrated into LIMS (laboratory information management systems) for efficient handling of results.
   
• Broad menu with continuous and true random access: Both platforms allow for continuous loading of specimens with true random access available for the first time in an integrated system. Laboratories can continue testing even when a lab worker loads additional specimens for use with different tests. The NeuMoDx 288 holds all the reagents required for up to 30 different assays on board, while the NeuMoDx 96 can accommodate up to 20 different tests. The systems offer unlimited access to process both commercial and LDTs for up to 288 preloaded specimens for the NeuMoDx 288 and up to 96 specimens for the NeuMoDx 96, providing a walkaway time of between 5 and 8 hours. The breadth of menu and the market-leading ease of use for conducting LDTs allow laboratories to consolidate all their testing needs onto a NeuMoDx platform. The two initial CE-IVD marked commercial assays focus on high-volume tests— the NeuMoDx CT/NG Assay for detection of the sexually transmitted Chlamydia trachomatis and Neisseria gonorrhoeae infections and the NeuMoDx GBS Assay for detection of Group B Streptococcus, a leading cause of life-threatening bacterial infections in newborn babies. A full menu for detection and monitoring of various diseases is under development, with many new assays to be launched in the coming months.
   
• Best-in-class workflow: The NeuMoDx 288 and 96 platforms are designed to address the widest range of customer needs among clinical laboratories by addressing specific throughput and lab space requirements. The NeuMoDx 96 requires less lab space than even the smallest instrument that is currently available for the same target applications and throughput, and the NeuMoDx 288 is about two to four times smaller than direct competitors with the same or higher throughput. All NeuMoDx systems use identical consumables and the same core technology, offering laboratories significant advantages in cost efficiency and ease of use compared to other systems. No reagent preparation is required, and onboard reagents are stored at room temperature for up to two months inside the system. The NeuMoDx systems have been designed for performance and cost leadership with features such as generic cartridges for universal nucleic acid extraction and PCR detection for all sample types and tests, and proprietary NeuDry dehydrated reagents that reduce waste and extend storage life.
   
• Strengthening QIAGEN’s Sample to Insight portfolio: NeuMoDx significantly strengthens QIAGEN’s portfolio of molecular diagnostic platforms. QIAGEN now has the ability to address the needs of any clinical laboratory worldwide— regardless of test volume processing requirements— with solutions using PCR or next-generation sequencing (NGS). In addition to the NeuMoDx systems for fully integrated PCR testing, QIAGEN offers these solutions:
  
       – QIAsymphony: The No.1 automation solution for processing samples for nucleic acid extraction from a broad range of samples (including blood, liquid biopsy, tissue, etc.) for use in PCR, NGS and other detection applications. In connection with the Rotor-Gene Q PCR, QIAsymphony is a leading modular platform that allows the highest level of flexibility in processing both commercial assays and LDTs.
       – QIAstat-Dx: The next generation in one-step multiplex molecular diagnostic systems that enable fast, cost-effective and flexible syndromic testing with novel Sample to Insight solutions based on PCR technology. Launched in 2018 in Europe, and planned for U.S. launch in 2019, QIAstat-Dx addresses the needs of clinical laboratories for near-patient testing for a range of conditions and helps reduce diagnostic uncertainty.
       – GeneReader NGS System: The first truly complete Sample to Insight next-generation sequencing (NGS) solution designed for any laboratory to deliver actionable results.

NeuMoDx Molecular, based in Ann Arbor, Mich., designs and develops molecular diagnostic solutions for hospital and clinical reference laboratories. Its patented platforms offer 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.
 
QIAGEN N.V., a Netherlands-based holding company, is a global provider of Sample to Insight solutions that enable customers to gain molecular insights from samples containing the building blocks of life. Its 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 June 30, 2018, QIAGEN employed approximately 4,800 people in over 35 locations worldwide.