Dive Brief:

• Qiagen has exercised its option to acquire NeuMoDx Molecular for its portfolio of PCR-based diagnostic automation systems.

• The deal, which has already received regulatory clearance, saw Qiagen pay $248 million for the approximately 80% of NeuMoDx that it did not already own. Qiagen secured an option to buy NeuMoDx outright when it bought a nearly 20% stake in the company in 2018.

• Ann Arbor, Michigan-based NeuMoDx makes automation systems designed to cut the time it takes laboratories to get test results. A multiplex test for influenza, respiratory syncytial virus and SARS-CoV-2 that runs on the automated devices is set to come to market in the fourth quarter.

Dive Insight:

Qiagen signed up to distribute the mid- and high-throughput versions of NeuMoDx’s PCR automation systems in major markets outside the U.S. in 2018. The agreement saw Qiagen take a 20% stake in its new partner and secure an option to buy the remaining 80% for $234 million, plus adjustments for cash, indebtedness and transaction costs. Since then, Qiagen and NeuMoDx have worked to expand the test menu, most recently in response to COVID-19.

NeuMoDx received emergency use authorization for its SARS-CoV-2 assay in March. The test enabled laboratories with NeuMoDx 288 or 96 molecular systems to automate the extraction of nucleic acid, preparation of isolated RNA and amplification and detection of sequences of SARS-CoV-2 genes. The test achieved clinical sensitivity and specificity of 100% in assessment data submitted to FDA.

The speed and volumes enabled by the automated process are a big part of NeuMoDx’s pitch. Qiagen said the NeuMoDx devices deliver "insights" in one hour, versus three hours for rival systems. BD, which filed a patent infringement suit against NeuMoDx last year, claims its BD Max System delivers results in “less than three hours.”

NeuMoDx is now working to apply the platform to flu, RSV and the novel coronavirus, three pathogens that will be circulating in the coming months and could cause patients to exhibit similar symptoms. The need for tests capable of telling which virus a patient is infected with, and thereby enabling the appropriate treatment, has attracted companies such as BioFire Diagnostics, DiaSorin Molecular and LabCorp. Qiagen also has a multi-virus product, the QIAstat-Dx Respiratory SARS-CoV-2 Panel. 

Qiagen will now take ultimate responsibility for getting NeuMoDx’s multi-virus test to market.

Those benefits could help Qiagen as it again plots a course as an independent company. Thermo Fisher Scientific agreed to acquire Qiagen earlier this year but was thwarted by investors who refused to sell their shares in the belief the offer undervalued the company, particularly as its coronavirus testing revenues grew.

Qiagen disclosed plans to buy NeuMoDx when Thermo Fisher’s bid failed. At the time, Qiagen said it expects NeuMoDx to “provide significant sales contributions” but has yet to share a more detailed analysis of the impact of the takeover.