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Qiagen, NeuMoDx Ink Partnership, Merger Agreement

NEW YORK (GenomeWeb) – Qiagen and NeuMoDx said today they have signed a strategic partnership and merger agreement related to the commercialization of a pair of fully integrated PCR-based molecular diagnostic systems.

As part of their strategic partnership, Qiagen will initially distribute the NeuMoDx 288 (high-throughput) and NeuMoDx 96 (mid-throughput) systems in Europe and other markets outside the US, where NeuMoDx will continue to market the products.

Under the terms of the merger agreement, Qiagen — which currently owns about 20 percent of Ann Arbor, Michigan-based NeuMoDx — has the right to acquire all remaining shares for a predetermined price of approximately $234 million, subject to the achievement of certain regulatory and operational milestones.

The NeuMoDx 288 and 96 systems combine patented extraction technologies, microfluidics, and silicon-based thermal cycling for fully automated, sample-to-answer, random-access molecular testing. The NeuMoDx 288 holds all reagents required to run up to 30 different assays simultaneously using up to 288 preloaded specimens, while the NeuMoDx 96 can accommodate up to 20 different tests using up to 96 preloaded specimens. Both systems can process commercial assays and laboratory-developed tests.

The US Food and Drug Administration granted the NeuMoDx 288 system 510(k) clearance in July, along with an assay for Group B Streptococcus (GBS). Both the 288 and 96 systems, the GBS test, and a CT/NG assay for detection of Chlamydia trachomatis and Neisseria gonorrhoeae have CE IVD marking.

Qiagen said that it will introduce the NeuMoDx systems at the European Society of Clinical Virology congress next week in Athens, Greece, along with the two CE-IVD marked assays.

Qiagen's partnership and merger agreement with NeuMoDx comes about nine months after the firm said it would acquire Barcelona-based Stat-Dx and its automated, cartridge-based molecular testing system — now called QiaStat-Dx — for syndromic molecular diagnostic testing and, eventually, immunoassays.

Both systems join Qiagen's legacy QiaSymphony modular laboratory platform, which integrates automated nucleic acid extraction for downstream PCR and NGS testing, including on the company's Rotor-Gene Q PCR system and GeneReader NGS system.

"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," Qiagen CEO Peer Schatz said in a statement.

He further noted that the NeuMoDx platforms "bring the simplicity of established clinical chemistry automation to molecular diagnostics along with rapid turnaround time in about 40 minutes," adding, "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."