Qiagen and NeuMoDx Partner on Fully Integrated Molecular Diagnostic Testing

Qiagen NV, Hilden, Germany, and NeuMoDx Molecular Inc, Ann Arbor, Mich, have announced a strategic partnership to commercialize two new fully integrated systems for the automation of polymerase chain reaction (PCR)-based testing. The next-generation sequencing (NGS) systems are designed to help molecular diagnostic laboratories process increasing clinical 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 outside of the United States. NeuMoDx will cover the United States directly. Additionally, the companies plan to implement certain Qiagen chemistries on the NeuMoDx systems.

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, subject to the achievement of certain regulatory and operational milestones. Qiagen currently owns approximately 19.9% of NeuMoDx.

Qiagen began European commercialization of the NeuMoDx systems with an initial assay menu based on CE 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 diagnostics (IVDs) and the ability to process both commercial tests and laboratory-developed tests (LDTs) in the most flexible and efficient manner. LDTs are diagnostic tests designed by clinical labs for their own use, and account for an important number of test requests and volumes.

“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,” says Peer M. Schatz, CEO of Qiagen. “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 40 minutes, and promises massive sample processing capacity and a broad menu of tests.”

“We are excited about joining forces with Qiagen to take NeuMoDx to the next level on a global basis. These revolutionary 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,” says 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.”

Key features of the NeuMoDx systems differentiate them from other laboratory-based PCR diagnostics systems. Most importantly, the NeuMoDx systems offer fully integrated operation, including every step from sample extraction through detection and results reporting. Other features include:

• Rapid access to insight. Melding high-throughput specimen processing capabilities with the industry’s fastest fully automated turnaround time produces results in about 40 minutes compared to competing systems requiring more than 3 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 can report results to ordering physicians more comprehensively and in a much shorter period of time, enabling faster treatment decisions and better outcomes. The speed of the NeuMoDx systems derives from innovations such as patented extraction technologies, advanced microfluidics, and silicon technology-based thermal cycling. Both systems can fully integrate with laboratory information management systems (LIMS).

• Broad menu with continuous and true random access. Both NeuMoDx platforms allow for continuous loading of specimens with true random access. Laboratories can continue testing even while a lab worker loads additional specimens for use with different tests. The NeuMoDx 288 holds all required reagents for up to 30 different assays, while the NeuMoDx 96 can accommodate up to 20 different tests. The systems can process both commercial diagnostics 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 ease of use for conducting LDTs enables laboratories to consolidate all their testing needs. The two initial CE marked commercial assays focus on high-volume tests: the NeuMoDx CT/NG assay for detection of the sexually transmitted infections Chlamydia trachomatis and Neisseria gonorrhoeae, 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 launching in the coming months.

• Best-in-class workflow. The platform designs address a wide range of customer needs for 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, while the NeuMoDx 288 is approximately 25% to 50% as large as direct competitors with the same or higher throughput. All NeuMoDx systems use identical consumables and the same core technology, offering laboratories cost efficiency and ease of use. No reagent preparation is required, and onboard reagents are stored at room temperature for up to 2 months inside the system. The systems also feature generic cartridges for universal nucleic acid extraction and PCR detection for all sample types and tests, as well as proprietary NeuDry dehydrated reagents that reduce waste and extend storage life.

NeuMoDx 96 and NeuMoDx 288 join the Qiagen line of products, including QIAsymphony, QIAstat-Dx, and GeneReader, forming a complementary portfolio of platforms for molecular diagnostics labs.

To learn more, visit Qiagen.