QIAGEN N.V. in the Netherlands and NeuMoDx Molecular Inc. in Ann Arbor today announced a strategic partnership to commercialize two new fully integrated systems for the automation of PCR (polymerase chain reaction) testing. The systems are 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) systems in Europe and other major markets worldwide outside of the United States. NeuMoDx will cover the United States directly.
Additionally, the companies are collaborating 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 (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 at the European Society of Clinical Virology (ESCV) congress (Sept. 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,” says 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 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.”
The 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.
The NeuMoDx systems offers 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 Molecular designs and develops molecular diagnostic solutions for hospital and clinical reference laboratories.
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. The company’s sample technologies isolate and process DNA, RNA, and proteins from blood, tissue, and other materials.
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