QIAGEN and NeuMoDx announce strategic partnership to offer next-generation systems for fully integrated molecular diagnostic testing
QIAGEN to launch two Sample to Insight systems in Europe and other markets, NeuMoDx to commercialize in the U.S. / Initial assay menu for infectious diseases and LDTs
Hilden, Germany, and Ann Arbor, Michigan, September 17, 2018 – QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) and NeuMoDx Molecular, Inc. today 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
QIAGEN intends to begin commercialization of the at the European Society of Clinical Virology (ESCV) congress (September 23-26 in Athens, Greece) 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, Chief Executive Officer 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 40 minutes 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 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,” said Jeff Williams, Chairman and Chief Executive Officer 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.
- 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.
- 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.