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Qiagen Gets FDA Clearance for CT/NG Test on NeuMoDx MDx Systems

NEW YORK – Qiagen announced on Monday that it has received clearance from the US Food and Drug Administration for a test to detect chlamydia and gonorrhea on its NeuMoDx systems.

Called the NeuMoDx CT/NG Assay 2.0, the test runs on the firm's NeuMoDx 96 and NeuMoDx 288 integrated PCR systems. It detects Chlamydia trachomatis and Neisseria gonorrhoeae, the bacterial pathogens that cause the sexually transmitted infections chlamydia and gonorrhea, respectively, from symptomatic and asymptomatic people.

The NeuMoDx continuous random-access systems extract DNA, perform RT-PCR, run up to 12 reactions simultaneously using room-temperature stable reagents and consumables, and deliver results in about one hour.

Qiagen acquired NeuMoDx in September 2020. At that time, the firm had Emergency Use Authorization from the US FDA for a COVID-19 assay as well as FDA clearance for a group B Streptococcus test on the platforms.

Qiagen also currently has 16 assays on the systems with CE-IVD registration, including tests for transplant-associated viruses, respiratory infections, blood-borne viruses, and sexual and reproductive health.

The CT/NG test marks the further expansion of the US NeuMoDx test menu, Qiagen said in a statement.

It also "marks an important milestone" as it is the first FDA clearance of a NeuMoDx assay for use on both systems, said Fernando Beils, senior VP and head of the Molecular Diagnostics Business Area for Qiagen. "This will be an important differentiator in building out the menu in the US to complement the broad menu offered in Europe and other countries," Beils added.