FDA Approves Emergency Use For QIAGEN’s NeuMoDx Multiplex Test

QIAGEN’s NeuMoDx test has received emergency use authorization from the U.S. Food and Drug Administration (FDA). The test helps to quickly identify and differentiate individuals suspected of respiratory viral infection consistent with COVID-19.

QIAGEN’s (QGEN) Senior Vice President, Jean-Pascal Viola, said, “The authorization of this new test will become a pivotal tool for the detection and differentiation of SARS-CoV-2 from influenza like illnesses, or ILIs.”

Viola further added, “With its ease of use and true random access, the NeuMoDx will help laboratories maintain throughput for this increased testing volume while continuing routine testing.”

The NeuMoDx test is an addition to the company’s broad range of testing and research solutions for COVID-19. This includes fast singleplex and multiplex PCR tests, fast syndromic solutions, QIAreach Antibody and Antigen tests and SARS-CoV-2 T-Cell tests.

The company has already commercialized the NeuMoDx test in the European Union and other markets accepting CE-IVD in November 2020. With this emergency use approval, it will now begin commercializing the test in the U.S.  (See QIAGEN stock analysis on TipRanks)

Last month, Wells Fargo analyst Dan Leonard reiterated a Hold rating on the stock with a $52 price target (5.6% upside potential). Reacting to a report of combination of Qiagen and Quidel,  Leonard viewed any such deal as unlikely.

Furthermore, William Blair analyst Brian Weinstein said about the report, “There was no scenario we came up where a combination of the different call points, geographies, sales forces, and perhaps most importantly, two extraordinarily different cultures would lead to synergy.”

Turning to rest of the Street, the stock has a Hold consensus rating alongside an average analyst price target of $57.16 (16% upside potential) based on 3 Buys, 5 Holds and 1 Sell. Shares have gained about 20.7% over the past year.

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