Hilden, Germany and Ann Arbor, MI 9/17/18—QIAGEN has announced that it plans merge with molecular diagnostics firm NeuMoDx, acquiring the 80% of the company it did not already own for $234 million. QIAGEN will distribute NeuMoDx’s automated PCR testing systems in Europe as well as other countries, excluding the US, in which NeuMoDx distributes them directly. QIAGEN chemistries will also be added to the platform. “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,” commented QIAGEN CEO Peer M. Schatz. The systems feature fully automated workflow, the ability to run both commercial assays and LDTs and can test 42 patient samples in an hour. The NeuMoDx systems is available in a high-throughput model (NeuMoDx 288), accommodating reagents for as many as 30 tests, and mid-throughput model (NeuMoDx 96) with reagents for up to 20 tests. Initially, QIAGEN will distribute the company’s CE-IVD assays for Group B Streptococcus (GBS) and Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) infections. This summer, NeuMoDex received US FDA 510(k) approval for the GBS assay.

Thierry Bernard, senior vice president of Molecular Diagnostics at QIAGEN, told IBO, “With the addition of NeuMoDx to its Sample to Insight portfolio, QIAGEN is now the only company that can address the needs of any lab worldwide with highly complementary automation systems, ranging from low-plex to high-plex, from low throughput to high throughput, and covering the most important technologies with PCR [and] NGS.” These systems include the QIAsymphony, which, with the Rotor-Gene Q PCR, works with both commercial assays and LDTs; the QIAstat-Dx, a one-step, PCR-based multiplex molecular diagnostic system for syndromic testing in near-patient settings; and the GeneReader NGS System.

Describing why NeuMoDx chose the GBS test as its initial assay to commercialize, NeuMoDx Molecular Chairman and CEO Jeff Williams said, “As a new company entering the molecular diagnostic market, NeuMoDx wished to validate the technology in the market by obtaining FDA clearance to market in an efficient manner with a valuable assay. The regulatory clearance pathway for Group B Strep is well defined, and testing for Group B Strep using molecular methods has grown rapidly over the last decade. We estimate nearly 4 million molecular Group B Strep tests are conducted every year in the US alone.” Commenting on QIAGEN’s investment, he noted,  “QIAGEN has the ambition to establish a footprint very quickly, so offering LDT and a combination with first approved FDA tests was necessary.” 

Regarding the CT/NG assay, Mr. Williams told IBO, “CT/NG as our second assay was an even more obvious choice. An estimated 80% of the single-to-low multiplex, multi–billion dollar clinical molecular market is comprised of testing for five assays:  HCV, HIV, HBV, HPV and CT/NG, with the most common assay in all of molecular diagnostics being CT/NG.” He added, “Given the ease of use, low cost and high throughput of the fully automated NeuMoDx 288 and 96 Molecular Systems, QIAGEN and NeuMoDx believe these systems have the opportunity to become true workhorses within the central lab, allowing laboratory personnel to finally consolidate all common molecular tests onto a single platform. To achieve this vision, the NeuMoDx Systems will offer the five major assays, certain esoteric and unique tests, and market leading LDT capability.”